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

June 17, 2024 updated by: I.M. Sechenov First Moscow State Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In December 2019, an outbreak of a novel coronavirus emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure. 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) (measuring esophageal pressure, transpulmonary pressure during inspiration and expiration), the patient's work of breathing (assessment of accessory muscles work) patient's comfort by visual-analog scale, gas exchange (by PaO2/FiO2 and Respiration Oxygenation Index (ROX-index), and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive pulmonary 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 105187
        • City clinical hospital named after F.I.Inozemtsev, Moscow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helmet-CPAP then Mask-CPAP
CPAP via Helmet 40 minutes, then CPAP via full face mask 40 minutes
Diagnostic test: Arterial blood gases
Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Diagnostic test: Respiratory rate (RR)
Measurement of respiratory rate by waveform analysis using a ventilator
Diagnostic test: Pulseoximeter
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
Diagnostic test: Assessment of accessory respiratory muscles work
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.
Diagnostic test: Esophageal pressure measurement
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
Diagnostic test: Discomfort Visual Analog Scale (VAS)
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
Diagnostic test: Noninvasive blood pressure
Noninvasive blood pressure
Diagnostic test: Heart rate
Heart rate calculation using electrocardiogram monitoring
Experimental: Mask-CPAP then Helmet-CPAP
CPAP via full face mask 40 minutes, then CPAP via helmet 40 minutes
Diagnostic test: Arterial blood gases
Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Diagnostic test: Respiratory rate (RR)
Measurement of respiratory rate by waveform analysis using a ventilator
Diagnostic test: Pulseoximeter
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
Diagnostic test: Assessment of accessory respiratory muscles work
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.
Diagnostic test: Esophageal pressure measurement
Esophageal pressure measurement on inspiration and expiration with calculation of delta esophageal pressure, transpulmonary pressure and delta transpulmonary pressure
Diagnostic test: Discomfort Visual Analog Scale (VAS)
From 1 to 10 points, where 1 point - maximal discomfort, 10 points - minimal discomfort.
Diagnostic test: Noninvasive blood pressure
Noninvasive blood pressure
Diagnostic test: Heart rate
Heart rate calculation using electrocardiogram monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory effort
Time Frame: 40 minutes
Delta esophageal pressure
40 minutes
Inspiratory delta transpulmonary pressure (stress)
Time Frame: 40 minutes
Inspiratory delta transpulmonary pressure
40 minutes
Expiratory delta transpulmonary pressure
Time Frame: 40 minutes
Expiratory delta transpulmonary pressure
40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 40 minutes
PaO2/FiO2 calculation
40 minutes
Respiratory rate
Time Frame: 40 minutes
Measurement of respiratory rate by waveform analysis using a ventilator
40 minutes
ROX index
Time Frame: 40 minutes
Peripheral capillary oxygen saturation (SpO2) measurement and the ROX-index calculation (SpO2/FiO2/RR)
40 minutes
Noninvasive blood pressure
Time Frame: 40 minutes
Noninvasive blood pressure
40 minutes
Heart rate
Time Frame: 40 minutes
Heart rate calculation using electrocardiogram monitoring
40 minutes
Patrick's score
Time Frame: 40 minutes
Patrick's score measurement, minimum 1point, maximum 5 points, higher score means worse outcome. 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.
40 minutes
Discomfort visual analog scale (VAS)
Time Frame: 40 minutes
Discomfort VAS score calculation, minimum 1point, maximum 10 points, higher score means better outcome
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Andrey I Yaroshetskiy, MD, PhD, ScD, Sechenov University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Helmet-Mask-ARF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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