Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507802
• Other study ID #: MRC-01-20-616
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: August 2021

Study information

• Verified date: July 2020
• Source: Hamad Medical Corporation
• Contact: Mohamed Z Peediyakkal, MD
• Phone: 0097450742399
• Email: MPeediyakkal2[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Corona Virus Disease
• Noninvasive Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Syndrome
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Qatar	Hazm Mebaireek General Hospital (HMGH)	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Estenssoro E, Dubin A, Laffaire E, Canales H, Sáenz G, Moseinco M, Pozo M, Gómez 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. — View Citation

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. Epub 2012 Aug 25. Erratum in: Intensive Care Med. 2012 Oct;38(10):1731-2. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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

Thille AW, Contou D, Fragnoli C, Córdoba-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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for Endotracheal Intubation	Number of patients requiring endotracheal intubation after application of helmet device	6 weeks
Secondary	Improvement in Oxygen Saturation	Improvement of oxygenation-defined as PaO2/FiO2 = 200 or increase from baseline by 100	2 weeks
Secondary	Ventilator-free Days	Duration of mechanical ventilation via endotracheal tube	28 days
Secondary	Intensive Care Unit Length of Stay	Number of days admitted to intensive care unit	4 weeks
Secondary	Overall Mortality	Death from any cause during hospitalization at time of enrollment	90 days
Secondary	Need for Proning	Need for proning during the hospital stay	up to 24 weeks
Secondary	Intensive Care Unit Mortality	Death from any cause during ICU hospitalization at time of enrollment	28 days
Secondary	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