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Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure (SOHO)

Primary Purpose

Acute Respiratory Failure, Hypoxemic Respiratory Failure

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Standard oxygen

High-flow nasal oxygen therapy

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring acute hypoxemic respiratory failure, de novo respiratory failure, high-flow nasal oxygen, standard oxygen

Eligibility Criteria

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

Inclusion Criteria:

All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:

Respiratory rate >25 breaths/min whatever the oxygen support
Pulmonary infiltrate,
PaO2/FiO2 ≤200 mmHg
Informed consent from the patient or relatives.

Exclusion Criteria:

PaCO2 > 45 mm Hg
Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min
Glasgow coma scale equal to or below 12 points
Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support
Cardiogenic pulmonary edema as main reason for acute respiratory failure
Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed)
Post-extubation respiratory failure within 7 days after extubation,
Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
Do not intubate order;
Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome.
Patients without any healthcare insurance scheme or not benefiting from it through a third party,
Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Sites / Locations

CHu PoitiersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard oxygen group

high-flow nasal cannula oxygen group

Arm Description

In order to maintain SpO2 between 92 and 96%

At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %

Outcomes

Primary Outcome Measures

Mortality at 28 days after randomization

Death between randomization and 28 days after randomization

Secondary Outcome Measures

Failure of the oxygenation strategy between randomization and D28

Intubation between randomization and D28

Mortality in ICU, in hospital, and day 90

Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.

Number of ventilation free days at Day 28

days alive and without intubation between day 1 and day 28

Duration of ICU and hospital stay

ICU and hospital stay between randomisation and end of stay in ICU and hospital

Complications during the ICU stay

Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.

Dyspnea

feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)

Comfort

comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"

Level of oxygenation

Oxygenation is assessed by arterial blood gas sample

Organ Failure during the 48 hours after intubation.

Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.

Duration between the time when prespecified criteria of intubation are met and intubation

interval between the time when prespecified criteria of intubation are met and intubation

Duration between treatment initiation and intubation

Interval between treatment initiation and intubation

Full Information

NCT ID

NCT04468126

First Posted

July 8, 2020

Last Updated

November 16, 2022

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04468126

Brief Title

Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

Acronym

SOHO

Official Title

Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2020 (Actual)

Primary Completion Date

January 11, 2023 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure, Hypoxemic Respiratory Failure

Keywords

acute hypoxemic respiratory failure, de novo respiratory failure, high-flow nasal oxygen, standard oxygen

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard oxygen group

Arm Type

Active Comparator

Arm Description

In order to maintain SpO2 between 92 and 96%

Arm Title

high-flow nasal cannula oxygen group

Arm Type

Experimental

Arm Description

At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %

Intervention Type

Other

Intervention Name(s)

Standard oxygen

Intervention Description

Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.

Intervention Type

Other

Intervention Name(s)

High-flow nasal oxygen therapy

Intervention Description

Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%

Primary Outcome Measure Information:

Title

Mortality at 28 days after randomization

Description

Death between randomization and 28 days after randomization

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Failure of the oxygenation strategy between randomization and D28

Description

Intubation between randomization and D28

Time Frame

Day 28

Title

Mortality in ICU, in hospital, and day 90

Description

Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.

Time Frame

Day 90

Title

Number of ventilation free days at Day 28

Description

days alive and without intubation between day 1 and day 28

Time Frame

Day 28

Title

Duration of ICU and hospital stay

Description

ICU and hospital stay between randomisation and end of stay in ICU and hospital

Time Frame

Day 90

Title

Complications during the ICU stay

Description

Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.

Time Frame

Day 90

Title

Dyspnea

Description

feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)

Time Frame

Hour 6

Title

Comfort

Description

comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"

Time Frame

Hour 6

Title

Level of oxygenation

Description

Oxygenation is assessed by arterial blood gas sample

Time Frame

Hour 48

Title

Organ Failure during the 48 hours after intubation.

Description

Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.

Time Frame

Day 28

Title

Duration between the time when prespecified criteria of intubation are met and intubation

Description

interval between the time when prespecified criteria of intubation are met and intubation

Time Frame

Day 28

Title

Duration between treatment initiation and intubation

Description

Interval between treatment initiation and intubation

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria: Respiratory rate >25 breaths/min whatever the oxygen support Pulmonary infiltrate, PaO2/FiO2 ≤200 mmHg Informed consent from the patient or relatives. Exclusion Criteria: PaCO2 > 45 mm Hg Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min Glasgow coma scale equal to or below 12 points Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support Cardiogenic pulmonary edema as main reason for acute respiratory failure Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed) Post-extubation respiratory failure within 7 days after extubation, Post-operative patients within 7 days after abdominal or cardiothoracic surgery, Do not intubate order; Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome. Patients without any healthcare insurance scheme or not benefiting from it through a third party, Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Pierre FRAT, PhD

Phone

05 49 44 60 64

Ext

+33

jean-pierre.frat@chu-poitiers.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Céline DELETAGE, PhD

Phone

05 49 44 38 54

Ext

+33

celine.deletage@chu-poitiers.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Pierre FRAT, PhD

Organizational Affiliation

CHU Poitiers

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHu Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-pierre FRAT, Dr

Phone

+33-5-49-44-40-07

jean-pierre.frat@chu-poitiers.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

36166027

Citation

Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613.

Results Reference

derived

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Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

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