Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intubation-free Survival in Acute Hypoxemic Respiratory Failure: the TRIPOD Randomized Clinical Trial

NCT06795971 | Recruiting DMC

• 1 other identifier: TRIPOD Study
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.

Conditions

Acute Hypoxemic Respiratory Failure; High-Flow Nasal Oxygen Therapy; Noninvasive Ventilation; Continuous Positive Airway Pressure (CPAP)

Outcome Measures

Primary Outcomes (1)

• Intubation-free survival rate

  The proportion of patients who intubation-free and alive within 28 days after randomization.

  From randomization to 28 days

Secondary Outcomes (12)

• 28-day mortality

  From randomization to 28 days

• Intubation rate within 28 days

  From randomization to 28 days

• A ranked composite score incorporating death and intubation through day 28

  From randomization to 28 days

• Meeting the prespecified criteria for intubation within 28 days.

  From randomization to 28 days

• ICU mortality

  From randomization to ICU discharge, assessed up to 60 days

Other Outcomes (6)

• Vomiting

  From randomization to 28 days

• Aspiration of gastric contents

  From randomization to 28 days

• Nasal/facial skin necrosis

  From randomization to 28 days

Study Arms (3)

Continuous Positive Airway Pressure

EXPERIMENTAL

Patients will receive continuous positive airway pressure

Device: Continuous Positive Airway Pressure

High-flow nasal oxygen

ACTIVE COMPARATOR

Patients will receive high-flow nasal oxygen

Device: High-flow nasal oxygen

Non-invasive ventilation

ACTIVE COMPARATOR

Patients will receive non-invasive ventilation

Device: Non-invasive ventilation

Interventions

Continuous Positive Airway Pressure DEVICE

1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was delivered to the patient through a face mask connected to an ICU ventilator. 2. PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. PEEP and FiO2 were titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. CPAP was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO.

Continuous Positive Airway Pressure

High-flow nasal oxygen DEVICE

1. Oxygen was passed through a heated humidifier (MR850, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 50 liters per minute and an FiO2 of 0.5 at initiation. HFNO heating temperature was prespecified at 37°C. 2. FiO2 will be titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. HFNO was applied for at least 2 calendar days.

High-flow nasal oxygen

Non-invasive ventilation DEVICE

1. Patients were placed at a 45-degree supine position, and noninvasive ventilation was also delivered to the patient through a face mask connected to an ICU ventilator. The mask most appropriate for the patient will be selected and adjusted to minimize leakage and pressure points. 2. The inspiratory positive airway pressure (pressure support plus PEEP) was initiated between 12 and 14 cm H2O, PEEP was started at 5 cm H2O with a FiO2 of 0.5 at initiation. FiO2 was titrated to maintain SpO2 between 94 and 98%, remaining constant for at least 5 min. 3. NIV was initiated with a first session of at least 4 h, the minimally required duration of noninvasive ventilation was 16 hours per day for at least 2 calendar days. Between noninvasive-ventilation sessions, patients received HFNO.

Non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 yrs;
• A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hg or less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 or less (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or (2) high-flow nasal cannula at 30L/min or higher, or (3) standard oxygen with oxygen flow rate of at least 10 L/min;
• Sign informed consent.

You may not qualify if:

• Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.
• Previous bout of mechanical ventilation during index hospitalization.
• Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.
• Moderate to severe cardiac insufficiency (New York Heart Association class \>II or left ventricular ejection fraction\<50%) or cardiogenic pulmonary edema.
• Hemodynamic dysfunction, defined as vasopressor dose \> 0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure \> 90 mm Hg.
• Impaired consciousness with a Glasgow coma score ≤ 12.
• Patients with urgent need for intubation, including respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support.
• Patients with contraindication to NIV according to the French consensus conference, patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, upper airway obstruction, hematemesis or severe facial trauma, thoracic or abdominal surgery in the previous 7 days.
• Pregnancy.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Continuous Positive Airway Pressure; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ling Liu, PhD

  Zhongda Hospital, School of Medicine, Southeast University

  STUDY DIRECTOR

Central Study Contacts

Ling Liu, PhD

CONTACT

+8613851435472; liulingdoctor@126.com

Yi Yang, PhD

CONTACT

+8613913966300; yiyiyang2004@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 28, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)