Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Comparison of The Clinical Outcomes of Non-Invasive Ventilation by Helmet vs Facemask in Patients With Acute Respiratory Distress Syndrome

The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure; Noninvasive Ventilation; Corona Virus Disease
• Intervention / Treatment: Device: Non invasive ventilation via helmet

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hazm Mebaireek General Hospital (HMGH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition
• Age: 18 and more

Exclusion Criteria:

• Patients with altered sensorium [Glasgow Coma Scale (GCS) less than 13]
• Pregnancy
• Hemodynamic instability
• Morbidly obese
• Patients with tracheostomy
• Severe acidosis [PH less than 7.15]
• Patients with glaucoma
• Patients with history of vertigo

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non invasive ventilation via helmet; Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.	Device: Non invasive ventilation via helmet; Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet
No Intervention: Non invasive ventilation via facemask; Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Endotracheal Intubation	Number of patients requiring endotracheal intubation after application of helmet device	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Oxygen Saturation	Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100	2 weeks
Ventilator-free Days	Duration of mechanical ventilation via endotracheal tube	28 days
Intensive Care Unit Length of Stay	Number of days admitted to intensive care unit	4 weeks
Overall Mortality	Death from any cause during hospitalization at time of enrollment	90 days
Need for Proning	Need for proning during the hospital stay	up to 24 weeks
Intensive Care Unit Mortality	Death from any cause during ICU hospitalization at time of enrollment	28 days
Patient Tolerability	the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance	28 days from randomization

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Mohamad Y Khatib, MD, Hamad Medical Corporation

Publications and helpful links

General Publications

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
• Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25. Erratum In: Intensive Care Med. 2012 Oct;38(10):1731-2.
• Hess DR. Noninvasive ventilation for acute respiratory failure. Respir Care. 2013 Jun;58(6):950-72. doi: 10.4187/respcare.02319.
• Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
• Thille AW, Contou D, Fragnoli C, Cordoba-Izquierdo A, Boissier F, Brun-Buisson C. Non-invasive ventilation for acute hypoxemic respiratory failure: intubation rate and risk factors. Crit Care. 2013 Nov 11;17(6):R269. doi: 10.1186/cc13103.
• Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.
• Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
• Frutos-Vivar F, Nin N, Esteban A. Epidemiology of acute lung injury and acute respiratory distress syndrome. Curr Opin Crit Care. 2004 Feb;10(1):1-6. doi: 10.1097/00075198-200402000-00001.
• Estenssoro E, Dubin A, Laffaire E, Canales H, Saenz G, Moseinco M, Pozo M, Gomez A, Baredes N, Jannello G, Osatnik J. Incidence, clinical course, and outcome in 217 patients with acute respiratory distress syndrome. Crit Care Med. 2002 Nov;30(11):2450-6. doi: 10.1097/00003246-200211000-00008.
• Greene R, Lind S, Jantsch H, Wilson R, Lynch K, Jones R, Carvalho A, Reid L, Waltman AC, Zapol W. Pulmonary vascular obstruction in severe ARDS: angiographic alterations after i.v. fibrinolytic therapy. AJR Am J Roentgenol. 1987 Mar;148(3):501-8. doi: 10.2214/ajr.148.3.501.
• Berg KM, Clardy P, Donnino MW. Noninvasive ventilation for acute respiratory failure: a review of the literature and current guidelines. Intern Emerg Med. 2012 Dec;7(6):539-45. doi: 10.1007/s11739-012-0856-z. Epub 2012 Sep 28.
• Schwartz AR, Kacmarek RM, Hess DR. Factors affecting oxygen delivery with bi-level positive airway pressure. Respir Care. 2004 Mar;49(3):270-5.
• Khatib MY, Peediyakkal MZ, Elshafei MS, Elzeer HS, Ananthegowda DC, Shahen MA, Abdaljawad WI, Shaik KS, Kannappilly N, Mohamed AS, Soliman AA, Nashwan AJ. Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome. Medicine (Baltimore). 2021 Jan 29;100(4):e24443. doi: 10.1097/MD.0000000000024443.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Virus Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: MRC-01-20-616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes