CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study

NCT06113432 | Completed DMC

• 1 other identifier: Helmet-Mask-ARF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.

Conditions

Pneumonia, Bacterial; Respiratory Failure; COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (3)

• Inspiratory effort

  Delta esophageal pressure

  40 minutes

• Inspiratory delta transpulmonary pressure (stress)

  Inspiratory delta transpulmonary pressure

  40 minutes

• Expiratory delta transpulmonary pressure

  Expiratory delta transpulmonary pressure

  40 minutes

Secondary Outcomes (7)

• Oxygenation

  40 minutes

• Respiratory rate

  40 minutes

• ROX index

  40 minutes

• Patrick's score

  40 minutes

• Discomfort visual analog scale (VAS)

  40 minutes

Study Arms (2)

Helmet-CPAP then Mask-CPAP

EXPERIMENTAL

CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes

Diagnostic Test: Arterial blood gases; Diagnostic Test: Respiratory rate (RR); Diagnostic Test: Pulseoximeter; Diagnostic Test: Assessment of accessory respiratory muscles work; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Discomfort Visual Analog Scale (VAS); Diagnostic Test: Noninvasive blood pressure; Diagnostic Test: Heart rate

Mask-CPAP then Helmet-CPAP

EXPERIMENTAL

CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes

Diagnostic Test: Arterial blood gases; Diagnostic Test: Respiratory rate (RR); Diagnostic Test: Pulseoximeter; Diagnostic Test: Assessment of accessory respiratory muscles work; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Discomfort Visual Analog Scale (VAS); Diagnostic Test: Noninvasive blood pressure; Diagnostic Test: Heart rate

Interventions

Arterial blood gases DIAGNOSTIC_TEST

Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Respiratory rate (RR) DIAGNOSTIC_TEST

Measurement of respiratory rate by waveform analysis using a ventilator

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Pulseoximeter DIAGNOSTIC_TEST

Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Assessment of accessory respiratory muscles work DIAGNOSTIC_TEST

Patrick score calculation. Score: 0. No visible tonic or phasic use of neck muscles. 1. Neck muscles taut but with no respiratory modulation (i.e., tonic activity). 2. Mild respiratory modulation in neck muscle contraction. 3. Moderate phasic activity (no supraclavicular or intercostal indrawing). 4. Vigorous phasic activity with indrawing. 5. Vigorous phasic activity with abdominal paradox.

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Esophageal pressure measurement DIAGNOSTIC_TEST

Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Discomfort Visual Analog Scale (VAS) DIAGNOSTIC_TEST

From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Noninvasive blood pressure DIAGNOSTIC_TEST

Noninvasive blood pressure

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Heart rate DIAGNOSTIC_TEST

Heart rate calculation using electrocardiogram monitoring

Helmet-CPAP then Mask-CPAP; Mask-CPAP then Helmet-CPAP

Eligibility Criteria

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

You may qualify if:

• Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia or COVID-19
• The ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
• Respiratory rate more than \> 25 per minute.
• Written informed consent

You may not qualify if:

• Patients who achieve the following target parameters with only low-flow oxygen therapy (flow up to 15 l/min): SpO2 \> 93%, the patient does not have a subjective feeling of fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
• Unstable hemodynamics (systolic blood pressure \<90 mm Hg or mean arterial pressure \<65 mm Hg) and/or lactic acidosis (lactate \>5 mmol/l and/or clinically diagnosed shock) and/or life-threatening arrhythmia,
• Metabolic acidosis (pH \<7.30);
• Patients who were in the ICU for less than 24 hours for any reason
• Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
• Cardiogenic pulmonary edema,
• Chronic diseases in the stag e of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
• Glasgow Coma Scale score \<14 points,
• Swallowing disorders
• Hypercapnia (PaCO2\>45 mmHg),
• The need for urgent tracheal intubation for any reason,
• Recent head surgery or anatomy that prevents the placement of a helmet or full face mask on the patient,
• Pregnancy,
• Inability to cooperate with staff

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

City clinical hospital named after F.I.Inozemtsev, Moscow

Moscow, 105187, Russia

Location

Related Publications (7)

• Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Care Med. 2002 Mar;30(3):602-8. doi: 10.1097/00003246-200203000-00019.

  PMID: 11990923 RESULT

• Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti A. Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study. Intensive Care Med. 2003 Oct;29(10):1680-7. doi: 10.1007/s00134-003-1931-8. Epub 2003 Aug 28.

  PMID: 14564379 RESULT

• Vargas F, Thille A, Lyazidi A, Campo FR, Brochard L. Helmet with specific settings versus facemask for noninvasive ventilation. Crit Care Med. 2009 Jun;37(6):1921-8. doi: 10.1097/CCM.0b013e31819fff93.

  PMID: 19384209 RESULT

• Chiumello D, Pelosi P, Carlesso E, Severgnini P, Aspesi M, Gamberoni C, Antonelli M, Conti G, Chiaranda M, Gattinoni L. Noninvasive positive pressure ventilation delivered by helmet vs. standard face mask. Intensive Care Med. 2003 Oct;29(10):1671-9. doi: 10.1007/s00134-003-1825-9. Epub 2003 Jun 12.

  PMID: 12802491 RESULT

• Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.

  PMID: 30871304 RESULT

• Saxena A, Nazir N, Pandey R, Gupta S. Comparison of Effect of Non-invasive Ventilation Delivered by Helmet vs Face Mask in Patients with COVID-19 Infection: A Randomized Control Study. Indian J Crit Care Med. 2022 Mar;26(3):282-287. doi: 10.5005/jp-journals-10071-24155.

  PMID: 35519929 RESULT

• Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.

  PMID: 31687831 RESULT

MeSH Terms

Conditions

Pneumonia, Bacterial; Respiratory Insufficiency

Interventions

Blood Gas Analysis; Respiratory Rate; Heart Rate

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Vital Signs; Physical Examination; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemodynamics; Cardiovascular Physiological Phenomena

Study Officials

• Andrey I Yaroshetskiy, MD, PhD, ScD

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients will receive all types of respiratory support (helmet CPAP 40 minutes followed by full face mask CPAP 40 minutes or full face mask CPAP 40 minutes followed by helmet CPAP 40 minutes) in a randomized crossover design.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: September 19, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 18, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)