search
Back to results

Positive End Espiratory Pressure Trial in Coronavirus Disease 19 Treated With Continuous Positive Airway Pressure

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PEEP Standard Protocol
Sponsored by
Santa Maria delle Grazie Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring COVID-19, PEEP trial, CPAP, lung ultrasound

Eligibility Criteria

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

Inclusion Criteria:

  • age > 18 years;
  • diagnosis of SARS-CoV-2 infection confirmed by means of RT-PCR on specimen from nasopharyngeal swab;
  • bilateral interstitial pneumonia at CT scan;
  • hypoxemic respiratory failure defined as PaO2/FiO2 < 200 at blood gas analyses.

Exclusion Criteria:

  • type 2 respiratory failure;
  • hemodynamic instability requiring vasopressors and/or inotropes support;
  • CT evidence of pneumothorax/pneumomediastinum;
  • concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)

Sites / Locations

  • COVID CARE UNIT Santa Maria delle Grazie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

All the patients undergo to helmet-CPAP setting PEEP at 10 cmH2O and performing a blood gas analysis after 2 hours

All the patients undergo to helmet-CPAP. PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. The best PEEP was setted as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value

Outcomes

Primary Outcome Measures

Primary outcome
composite of hospital mortality and need of endotracheal intubation

Secondary Outcome Measures

Secondary outcome
effect on P/F ratio at blood gas analyses

Full Information

First Posted
December 31, 2021
Last Updated
January 4, 2022
Sponsor
Santa Maria delle Grazie Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05178160
Brief Title
Positive End Espiratory Pressure Trial in Coronavirus Disease 19 Treated With Continuous Positive Airway Pressure
Official Title
Lung Ultrasound-Guided PEEP Titration Versus Standard Protocol in Patients With COVID-19 ARDS Treated With CPAP: a Single Center Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Maria delle Grazie Hospital

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
Consecutive patients with hypoxemic respiratory failure, CT evidence of bilateral pneumonia and diagnosis of Coronavirus Disease 19 (COVID-19) with molecular nasopharyngeal swab consecutively admitted to the COVID Care Unit of the "Santa Maria delle Grazie" Hospital were enrolled. All the patients with clinical indication for Continuous Positive Airway Pressure (CPAP) were randomized 1:1 into two groups: Group A received a fixed Positive End Expiratory Pressure (PEEP) of 10 centimetre of water (cmH2O), Group B underwent the PEEP trial to identify the optimal PEEP (defined as the highest value that preceded the appearance of the "lung pulse" at lung ultrasound and that determined an increase in PaO2/FiO2 by at least 20%). Primary endpoint was defined as a composite in-hospital mortality+intubation, secondary endpoint was the improvement of PaO2/FiO2. As safety indicator, the incidence of pneumothorax was collected.
Detailed Description
Consecutive COVID-19 patients affected by Acute Respiratory Syndrome (ARDS) admitted to COVID Care Unit of "Santa Maria delle Grazie" Hospital, Pozzuoli (Naples, Italy), were prospectively enrolled in the study. Inclusion criteria were: age > 18 years, diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) infection confirmed by means of a nucleic acid test by real-time reverse transcription polymerase chain reaction (RT-PCR) on specimen from nasopharyngeal swab, bilateral interstitial pneumonia at CT scan; hypoxemic respiratory failure defined as PaO2 (partial pressure of oxygen) to FiO2 (fraction of inspired oxygen) ratio < 200. As exclusion criteria were considered: type 2 respiratory failure; hemodynamic instability requiring vasopressors and/or inotropes support; CT evidence of pneumothorax/pneumomediastinum; concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis) who could affect the prognosis independent from COVID - 19. All the patients enrolled underwent clinical history, physical examination, laboratory tests, arterial blood gas analysis, lung ultrasound, chest CT. During the hospital stay, the patients were treated according to the standard and experimental protocol available; therapies administered, and collateral effects were collected. All participants gave their written informed consent. All the patients eligible to receive CPAP were consecutively 1:1 randomized to PEEP trial (Group A) or standard treatment (Group B). In the Group A, PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. PEEP responsiveness was evaluated comparing ultrasound findings and arterial blood gas parameters during oxygen supplementation with helmet-CPAP at different PEEP levels (5, 7.5 and 10, respectively), maintaining the same FiO2. A PEEP-responder is defined as a subject with clinical and/or arterial blood gases improvement with helmet-CPAP without signs of lung hyperinflation. The best PEEP was defined as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value. In the Standard practice group CPAP was set at 10 cmH2O for all patients and a blood gas analysis was performed after 2 hours. Endotracheal intubation was considered in presence of impaired respiratory mechanics, worsening of respiratory acidosis, decreased mental status. Primary outcome was defined by a composite of hospital mortality and need of endotracheal intubation. Secondary outcome was considered the effect of CPAP on PaO2/FiO2 and respiratory rate. As a safety indicator the incidence of pneumothorax was considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
Keywords
COVID-19, PEEP trial, CPAP, lung ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
All the patients undergo to helmet-CPAP setting PEEP at 10 cmH2O and performing a blood gas analysis after 2 hours
Arm Title
Group B
Arm Type
Experimental
Arm Description
All the patients undergo to helmet-CPAP. PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. The best PEEP was setted as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value
Intervention Type
Other
Intervention Name(s)
PEEP Standard Protocol
Intervention Description
All the patients treated with CPAP receive a PEEP standard of 10 cmH2O with a fixed FiO2
Primary Outcome Measure Information:
Title
Primary outcome
Description
composite of hospital mortality and need of endotracheal intubation
Time Frame
From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
Secondary Outcome Measure Information:
Title
Secondary outcome
Description
effect on P/F ratio at blood gas analyses
Time Frame
From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.
Other Pre-specified Outcome Measures:
Title
Safety outcome
Description
incidence of pneumothorax and/or pneumomediastinum
Time Frame
From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 years; diagnosis of SARS-CoV-2 infection confirmed by means of RT-PCR on specimen from nasopharyngeal swab; bilateral interstitial pneumonia at CT scan; hypoxemic respiratory failure defined as PaO2/FiO2 < 200 at blood gas analyses. Exclusion Criteria: type 2 respiratory failure; hemodynamic instability requiring vasopressors and/or inotropes support; CT evidence of pneumothorax/pneumomediastinum; concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio G Numis, MD
Organizational Affiliation
Santa Maria delle Grazie Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
COVID CARE UNIT Santa Maria delle Grazie Hospital
City
Pozzuoli
State/Province
Naples
ZIP/Postal Code
80078
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33011929
Citation
Bosso G, Allegorico E, Pagano A, Porta G, Serra C, Minerva V, Mercurio V, Russo T, Altruda C, Arbo P, De Sio C, Dello Vicario F, Numis FG. Lung ultrasound as diagnostic tool for SARS-CoV-2 infection. Intern Emerg Med. 2021 Mar;16(2):471-476. doi: 10.1007/s11739-020-02512-y. Epub 2020 Oct 3.
Results Reference
result
PubMed Identifier
32629100
Citation
Pagano A, Porta G, Bosso G, Allegorico E, Serra C, Dello Vicario F, Minerva V, Russo T, Altruda C, Arbo P, Mercurio V, Numis FG. Non-invasive CPAP in mild and moderate ARDS secondary to SARS-CoV-2. Respir Physiol Neurobiol. 2020 Sep;280:103489. doi: 10.1016/j.resp.2020.103489. Epub 2020 Jul 3.
Results Reference
result
PubMed Identifier
29404202
Citation
Paolini V, Faverio P, Aliberti S, Messinesi G, Foti G, Sibila O, Monzani A, De Giacomi F, Stainer A, Pesci A. Positive end expiratory pressure in acute hypoxemic respiratory failure due to community acquired pneumonia: do we need a personalized approach? PeerJ. 2018 Jan 30;6:e4211. doi: 10.7717/peerj.4211. eCollection 2018.
Results Reference
result

Learn more about this trial

Positive End Espiratory Pressure Trial in Coronavirus Disease 19 Treated With Continuous Positive Airway Pressure

We'll reach out to this number within 24 hrs