Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

NCT ID: NCT06213168

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1084 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-03-31

Brief Summary

De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.

Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.

The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial

Conditions

De Novo Hypoxemic Acute Respiratory Failure (hARF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

HFNC

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization.

Group Type: EXPERIMENTAL

HFNC

Intervention Type: OTHER

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

HFNC with CPAP

Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Group Type: EXPERIMENTAL

HFNC

Intervention Type: OTHER

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

CPAP and HFNC

Intervention Type: OTHER

Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Interventions

HFNC

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

Intervention Type: OTHER

CPAP and HFNC

Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Intervention Type: OTHER

Other Intervention Names

High flow nasal cannula oxygen therapy; Continuous positive airway pressure and High flow nasal canulae

Eligibility Criteria

Inclusion Criteria

1. Adults (≥ 18 years old)

2. Admitted in the ICU for ≤ 24 hours

3. De novo hARF defined by the three following criteria:

1. Respiratory rate > 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration

2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.

3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan

4. Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent

Exclusion Criteria

1. Refusal of study participation by the patient or the proxy

2. Anatomical factors precluding the use of a nasal cannula or CPAP

3. Long term oxygen

4. Home CPAP or NIV

5. Hypercapnia indicating NIV (PaCO2 > 45 mmHg)

6. Isolated cardiogenic pulmonary oedema indicating NIV

7. Known pregnancy or breastfeeding

8. Absence of coverage by the French statutory health care insurance system

9. Surgery within the last 6 days

10. Use of vasopressors (norepinephrine>0.3 mcg/kg/min)

11. Glasgow coma scale < 13

12. Urgent need for endotracheal intubation

13. Patients at an end-of-life stage receiving compational oxygenation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alexandre DEMOULE

Role: CONTACT

alexandre.demoule@aphp.fr

+33 (0)1 42 16 77 61

Other Identifiers

APHP220813

Identifier Type: -

Identifier Source: org_study_id