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Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia (VT4COVID)

Primary Purpose

Acute Respiratory Distress Syndrome, COVID19, Sars-CoV2

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PROTECTIVE VENTILATION
ULTRAPROTECTIVE VENTILATION
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring COVID19, ARDS, MECHANICAL VENTILATION, ULTRAPROTECTIVE VENTILATION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults aged 18 years or older
  • ARDS according to the Berlin definition
  • COVID-19 pneumonia confirmed by RT-PCR
  • Acute respiratory failure not fully explained by left ventricular failure or sodium overload
  • Bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules
  • Invasive mechanical ventilation with PaO2/FiO2 ≤ 150 mm Hg and PEEP ≥ 5 cm H2O with a tidal volume below or equal to 6 ml per kilogram of predicted body weight
  • Continuous intravenous sedation as part of ARDS treatment

Exclusion Criteria:

  • Exclusion criteria related to ARDS history

    • ARDS onset more than 48 hours before inclusion
    • previous inclusion in present study

  • Exclusion criteria related to ARDS severity or complications

    • arterial pH < 7.21 despite respiratory rate set to 35/min at the time of inclusion
    • patient under any extracorporeal CO2 removal technique or ECMO
    • pneumothorax or bronchopleural fistula

  • Exclusion criteria related to comorbidities

    • suspected intracranial hypertension
    • severe chronic obstructive pulmonary disease defined by a GOLD score ≥ 3
    • chronic respiratory failure under home oxygen or non-invasive ventilation
    • chronic respiratory failure requiring long term oxygen or non-invasive ventilation
    • obesity with body weight over height ratio greater than 1 kg/cm
    • sickle cell disease
    • bone marrow transplant < 6 months
    • burn injury with extension greater than 30% of body surface area
    • cirrhosis with Child-Pugh score C
    • advance directives to withhold or withdraw life sustaining treatment

  • Exclusion criteria related to legislation

    • Patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies
    • pregnancy, lactating women
    • patient under a legal protective measure.
    • lack of affiliation to social security as required by French regulation
    • lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)

Sites / Locations

  • Service de Médecine Intensive Réanimation CHU Gabriel MontpiedRecruiting
  • Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble AlpesRecruiting
  • Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de LyonRecruiting
  • Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de LyonRecruiting
  • Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de LyonRecruiting
  • Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de LyonRecruiting
  • Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint LucRecruiting
  • Service de Réanimation Clinique de la Sauvegarde
  • Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de LyonRecruiting
  • Service de Réanimation Centre hospitalier Annecy Genevois
  • Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PROTECTIVE VENTILATION

ULTRAPROTECTIVE VENTILATION

Arm Description

Protective ventilation with tidal volume 6 mL/kg of predicted body weight

Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20

Outcomes

Primary Outcome Measures

A composite score based on all-cause mortality and the number of ventilator free-days (VFD)
For an alive patient at day 90, the score will be built as follow: a value +1 will be given for comparisons to dead patients and alive patients with a lower number of VFD. For comparisons to alive patients with a higher number of VFD a value -1 will be given and in case of identical number of VFD a value 0 will be given. For a dead patient a value -1 will be given for comparisons to alive patients and 0 for comparisons to dead patients. For a given patients the score will correspond to the sum of values resulting to the comparison to all patients of the other group. A higher score indicates a more favorable result.

Secondary Outcome Measures

All-cause mortality (intention to treat)
All-cause mortality with analysis in intention to treat, i.e. each patient will be analyzed in his initial randomization group regardless of whether the allocated strategy was effectively applied or not.
Ventilator-free days (VFD)
VFD will be computed as follows from the day of inclusion: VFD= 0 if the patient dies between inclusion and day 60 VFD = 60-x if the patient is successfully weaned from invasive mechanical ventilation x days after inclusion. Successful weaning from mechanical ventilation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) VFD= 0 if the patient is mechanically ventilated for more than 60 days after inclusion
All-cause mortality with per protocol analysis
Per protocol analysis will be carried out by comparing the group of patients in whom median daily tidal volume from inclusion to weaning of deep sedation will be lower of equal to 4.2 ml/kg of predicted body weight to the group of patients in whom median tidal volume from inclusion to weaning of deep sedation will be greater than 4.2 ml/kg of predicted body weight, whatever the patients' initial randomization group. Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Time to successful extubation
Successful extubation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) Data will be right censored at 60 days and death will be taken into account as a competing risk.
Length of hospital stay
Data will be right censored at 90 days and death will be taken into account as a competing risk.
Respiratory parameters assessed daily from inclusion to weaning of deep sedation or 14 days whichever comes first
Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Daily sedation dose during the first 14 days of the study
Doses of the following drugs used for deep sedation will be assessed daily: midazolam, propofol and opioid. Opioid dose will be expressed as morphine equivalent with the following conversion factor: 1µg of sufentanil = 10 µg of fentanyl = 1 mg of morphine
Rate of use of rescue therapies
Rescue therapies are any therapy among the following ones: neuromuscular blocking agents, prone position, nitric oxide, recruitment maneuvers, ECMO
Incidence density rate of severe mixed acidosis
Severe mixed acidosis is defined by the association of pH<7.15 and PaCO2>45 mm Hg.
Incidence density rate of ventilator associated pneumonia
Ventilator associated pneumonia will be defined as any pneumonia acquired under mechanical ventilation after inclusion.
Incidence density rate of acute cor pulmonale
Acute cor pulmonale is defined by the association of right ventricle dilatation (right ventricle surface / left ventricle surface >0,6) and septal dyskinesia assessed by echocardiography
Incidence density rate of barotrauma
Barotrauma is defined by any pneumothorax OR pneumomediastinum OR subcutaneous emphysema, OR pneumatocele of more than 2 cm detected on image examinations.
Incidence density rate of any serious adverse events
Serious adverse event is any life threatening event OR any event resulting in death.
Cognitive impairment assessed by phone call using the Telephone Montreal Cognitive Assessment (T-MoCA) test
The Telephone Montreal Cognitive Assessment score will be assessed by phone call. The total score ranges from 0 to 30; higher scores being associated to a better outcome.
Quality of life assessed by the RAND 36-Item Health Survey (SF-36) score
The RAND 36-Item Health Survey (SF-36) score will be assessed by phone call. The score ranges from 0 to 100; higher scores being associated to a better outcome.
Post-traumatic stress disorder assessed by the Impact of Event Scale - revised (IES-R) score by phone call
The Impact of Event Scale - revised (IES-R) score will be assessed by phone call. The total score ranges from 0 to 88; higher scores being associated to a worse outcome.
Cost-efficacy ratio of the innovative strategy compared to the reference strategy
The cost-efficacy ratio will be computed as the ratio of cost difference on efficacy difference between the intervention arm and the reference arm. The costs taken into account will be the direct hospitalized costs. The efficacy will be assessed as the number of days alive free from mechanical ventilation.

Full Information

First Posted
April 8, 2020
Last Updated
February 12, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04349618
Brief Title
Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia
Acronym
VT4COVID
Official Title
Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O). Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, COVID19, Sars-CoV2, Pneumonia
Keywords
COVID19, ARDS, MECHANICAL VENTILATION, ULTRAPROTECTIVE VENTILATION

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PROTECTIVE VENTILATION
Arm Type
Active Comparator
Arm Description
Protective ventilation with tidal volume 6 mL/kg of predicted body weight
Arm Title
ULTRAPROTECTIVE VENTILATION
Arm Type
Experimental
Arm Description
Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20
Intervention Type
Other
Intervention Name(s)
PROTECTIVE VENTILATION
Intervention Description
Protective ventilation with tidal volume 6 mL/kg of predicted body weight further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
Intervention Type
Other
Intervention Name(s)
ULTRAPROTECTIVE VENTILATION
Intervention Description
Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
Primary Outcome Measure Information:
Title
A composite score based on all-cause mortality and the number of ventilator free-days (VFD)
Description
For an alive patient at day 90, the score will be built as follow: a value +1 will be given for comparisons to dead patients and alive patients with a lower number of VFD. For comparisons to alive patients with a higher number of VFD a value -1 will be given and in case of identical number of VFD a value 0 will be given. For a dead patient a value -1 will be given for comparisons to alive patients and 0 for comparisons to dead patients. For a given patients the score will correspond to the sum of values resulting to the comparison to all patients of the other group. A higher score indicates a more favorable result.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
All-cause mortality (intention to treat)
Description
All-cause mortality with analysis in intention to treat, i.e. each patient will be analyzed in his initial randomization group regardless of whether the allocated strategy was effectively applied or not.
Time Frame
90-day after inclusion
Title
Ventilator-free days (VFD)
Description
VFD will be computed as follows from the day of inclusion: VFD= 0 if the patient dies between inclusion and day 60 VFD = 60-x if the patient is successfully weaned from invasive mechanical ventilation x days after inclusion. Successful weaning from mechanical ventilation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) VFD= 0 if the patient is mechanically ventilated for more than 60 days after inclusion
Time Frame
day 60 after inclusion
Title
All-cause mortality with per protocol analysis
Description
Per protocol analysis will be carried out by comparing the group of patients in whom median daily tidal volume from inclusion to weaning of deep sedation will be lower of equal to 4.2 ml/kg of predicted body weight to the group of patients in whom median tidal volume from inclusion to weaning of deep sedation will be greater than 4.2 ml/kg of predicted body weight, whatever the patients' initial randomization group. Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Time Frame
90-day
Title
Time to successful extubation
Description
Successful extubation is defined by extubation without reintubation within at least 48 hours (or weaning from mechanical ventilation for at least 48 hours in patients with tracheostomy) Data will be right censored at 60 days and death will be taken into account as a competing risk.
Time Frame
60 days
Title
Length of hospital stay
Description
Data will be right censored at 90 days and death will be taken into account as a competing risk.
Time Frame
90 days
Title
Respiratory parameters assessed daily from inclusion to weaning of deep sedation or 14 days whichever comes first
Description
Weaning of deep sedation is defined by a Richmond Agitation Sedation (RASS) score greater than -3 for at least 48 hours.
Time Frame
14 days
Title
Daily sedation dose during the first 14 days of the study
Description
Doses of the following drugs used for deep sedation will be assessed daily: midazolam, propofol and opioid. Opioid dose will be expressed as morphine equivalent with the following conversion factor: 1µg of sufentanil = 10 µg of fentanyl = 1 mg of morphine
Time Frame
14 days
Title
Rate of use of rescue therapies
Description
Rescue therapies are any therapy among the following ones: neuromuscular blocking agents, prone position, nitric oxide, recruitment maneuvers, ECMO
Time Frame
14 days
Title
Incidence density rate of severe mixed acidosis
Description
Severe mixed acidosis is defined by the association of pH<7.15 and PaCO2>45 mm Hg.
Time Frame
ICU stay
Title
Incidence density rate of ventilator associated pneumonia
Description
Ventilator associated pneumonia will be defined as any pneumonia acquired under mechanical ventilation after inclusion.
Time Frame
ICU stay
Title
Incidence density rate of acute cor pulmonale
Description
Acute cor pulmonale is defined by the association of right ventricle dilatation (right ventricle surface / left ventricle surface >0,6) and septal dyskinesia assessed by echocardiography
Time Frame
ICU stay
Title
Incidence density rate of barotrauma
Description
Barotrauma is defined by any pneumothorax OR pneumomediastinum OR subcutaneous emphysema, OR pneumatocele of more than 2 cm detected on image examinations.
Time Frame
ICU stay
Title
Incidence density rate of any serious adverse events
Description
Serious adverse event is any life threatening event OR any event resulting in death.
Time Frame
ICU stay
Title
Cognitive impairment assessed by phone call using the Telephone Montreal Cognitive Assessment (T-MoCA) test
Description
The Telephone Montreal Cognitive Assessment score will be assessed by phone call. The total score ranges from 0 to 30; higher scores being associated to a better outcome.
Time Frame
Day 365 after inclusion
Title
Quality of life assessed by the RAND 36-Item Health Survey (SF-36) score
Description
The RAND 36-Item Health Survey (SF-36) score will be assessed by phone call. The score ranges from 0 to 100; higher scores being associated to a better outcome.
Time Frame
Day 365 after inclusion
Title
Post-traumatic stress disorder assessed by the Impact of Event Scale - revised (IES-R) score by phone call
Description
The Impact of Event Scale - revised (IES-R) score will be assessed by phone call. The total score ranges from 0 to 88; higher scores being associated to a worse outcome.
Time Frame
Day 365 after inclusion
Title
Cost-efficacy ratio of the innovative strategy compared to the reference strategy
Description
The cost-efficacy ratio will be computed as the ratio of cost difference on efficacy difference between the intervention arm and the reference arm. The costs taken into account will be the direct hospitalized costs. The efficacy will be assessed as the number of days alive free from mechanical ventilation.
Time Frame
Day 90 after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 years or older ARDS according to the Berlin definition COVID-19 pneumonia confirmed by RT-PCR Acute respiratory failure not fully explained by left ventricular failure or sodium overload Bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules Invasive mechanical ventilation with PaO2/FiO2 ≤ 150 mm Hg and PEEP ≥ 5 cm H2O with a tidal volume below or equal to 6 ml per kilogram of predicted body weight Continuous intravenous sedation as part of ARDS treatment Exclusion Criteria: Exclusion criteria related to ARDS history ARDS onset more than 48 hours before inclusion previous inclusion in present study Exclusion criteria related to ARDS severity or complications arterial pH < 7.21 despite respiratory rate set to 35/min at the time of inclusion patient under any extracorporeal CO2 removal technique or ECMO pneumothorax or bronchopleural fistula Exclusion criteria related to comorbidities suspected intracranial hypertension severe chronic obstructive pulmonary disease defined by a GOLD score ≥ 3 chronic respiratory failure under home oxygen or non-invasive ventilation chronic respiratory failure requiring long term oxygen or non-invasive ventilation obesity with body weight over height ratio greater than 1 kg/cm sickle cell disease bone marrow transplant < 6 months burn injury with extension greater than 30% of body surface area cirrhosis with Child-Pugh score C advance directives to withhold or withdraw life sustaining treatment Exclusion criteria related to legislation Patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies pregnancy, lactating women patient under a legal protective measure. lack of affiliation to social security as required by French regulation lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe RICHARD, Pr
Phone
04 26 10 92 72
Ext
+33
Email
j-christophe.richard@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Loredana BABOI
Email
loredana.baboi@chu-lyon.fr
Facility Information:
Facility Name
Service de Médecine Intensive Réanimation CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DUPUIS, Dr
Phone
04 73 75 07 50
Ext
+33
Email
cdupuis1@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Claire DUPUIS, Dr
Facility Name
Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, Pr
Phone
04-76-76-87-79
Ext
+33
Email
nterzi@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, Pr
Facility Name
Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent ARGAUD, Pr
Phone
04 72 11 28 62
Ext
+33
Email
laurent.argaud@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Laurent ARGAUD, Pr
Facility Name
Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas RIMMELE, Pr
Phone
04 72 11 07 84
Ext
+33
Email
thomas.rimmele@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Thomas RIMMELE, Pr
Facility Name
Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hodane YONIS, Dr
Phone
04 72 07 17 62
Ext
+33
Email
hodane.yonis@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Hodane YONIS, Dr
First Name & Middle Initial & Last Name & Degree
Jean-Christophe RICHARD, Pr
Facility Name
Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric AUBRUN, Pr
Phone
04 26 10 92 34
Ext
+33
Email
frederic.aubrun@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Frédéric AUBRUN, Pr
Facility Name
Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian POMMIER, Dr
Phone
04 78 61 82 09
Ext
+33
Email
cpommier@ch-stjoseph-stluc-lyon.fr
First Name & Middle Initial & Last Name & Degree
Christian POMMIER, Dr
Facility Name
Service de Réanimation Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand DELANNOY, Dr
First Name & Middle Initial & Last Name & Degree
Bertrand DELANNOY, Dr
Facility Name
Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent WALLET, MD
Phone
04 78 86 21 62
Ext
+33
Email
florent.wallet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Florent WALLET, Dr
Facility Name
Service de Réanimation Centre hospitalier Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel MULLER, Dr
Phone
04 50 63 60 30
Ext
+33
Email
mmuller@ch-annecygenevois.fr
First Name & Middle Initial & Last Name & Degree
Michel MULLER, Dr
Facility Name
Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-Etienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume THIERY, Pr
Phone
04 77 12 78 62
Ext
+33
Email
guillaume.thiery@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Guillaume THIERY, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34635128
Citation
Richard JC, Yonis H, Bitker L, Roche S, Wallet F, Dupuis C, Serrier H, Argaud L, Thiery G, Delannoy B, Pommier C, Abraham P, Muller M, Aubrun F, Sigaud F, Rigault G, Joffredo E, Mezidi M, Terzi N, Rabilloud M. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial. Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.
Results Reference
derived

Learn more about this trial

Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia

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