Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

NCT04507802 | Unknown DMC FDA Device

• 1 other identifier: MRC-01-20-616
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Acute Respiratory Distress Syndrome; Noninvasive Ventilation; Corona Virus Disease; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Need for Endotracheal Intubation

  Number of patients requiring endotracheal intubation after application of helmet device

  6 weeks

Secondary Outcomes (7)

• Improvement in Oxygen Saturation

  2 weeks

• Ventilator-free Days

  28 days

• Intensive Care Unit Length of Stay

  4 weeks

• Overall Mortality

  90 days

• Need for Proning

  up to 24 weeks

Study Arms (2)

Non invasive ventilation via helmet

EXPERIMENTAL

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

Non invasive ventilation via facemask

NO INTERVENTION

Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask

Interventions

Non invasive ventilation via helmet DEVICE

Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet

Non invasive ventilation via helmet

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 Respiratory Distress Syndrome) ARDS as per Berlin definition
• Age: 18 and more

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hazm Mebaireek General Hospital (HMGH)

Doha, Qatar

Location

Related Publications (14)

• 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.

  PMID: 15166842 BACKGROUND

• 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.

  PMID: 12441753 BACKGROUND

• 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.

  PMID: 26903337 BACKGROUND

• 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 22926653 BACKGROUND

• 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.

  PMID: 3492876 BACKGROUND

• Hess DR. Noninvasive ventilation for acute respiratory failure. Respir Care. 2013 Jun;58(6):950-72. doi: 10.4187/respcare.02319.

  PMID: 23709194 BACKGROUND

• 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.

  PMID: 23054404 BACKGROUND

• 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.

  PMID: 22318634 BACKGROUND

• 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.

  PMID: 24215648 BACKGROUND

• 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.

  PMID: 17133177 BACKGROUND

• Schwartz AR, Kacmarek RM, Hess DR. Factors affecting oxygen delivery with bi-level positive airway pressure. Respir Care. 2004 Mar;49(3):270-5.

  PMID: 14982647 BACKGROUND

• 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.

  PMID: 27179847 BACKGROUND

• 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.

  PMID: 33530249 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mohamad Y Khatib, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Z Peediyakkal, MD

CONTACT

0097450742399; MPeediyakkal2@hamad.qa

Abdulqadir J Nashwan, MSc

CONTACT

0097466473549; anashwan@hamad.qa

Study Design

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

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-07

Locations

QA (1)