search
Back to results

Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome, Noninvasive Ventilation, Corona Virus Disease

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Non invasive ventilation via helmet
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hazm Mebaireek General Hospital (HMGH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Non invasive ventilation via helmet

Non invasive ventilation via facemask

Arm Description

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

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

Outcomes

Primary Outcome Measures

Need for Endotracheal Intubation
Number of patients requiring endotracheal intubation after application of helmet device

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2020
Last Updated
August 7, 2020
Sponsor
Hamad Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04507802
Brief Title
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome
Official Title
Comparison of The Clinical Outcomes of Non-Invasive Ventilation by Helmet vs Facemask in Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Noninvasive Ventilation, Corona Virus Disease, Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non invasive ventilation via helmet
Arm Type
Experimental
Arm Description
Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Arm Title
Non invasive ventilation via facemask
Arm Type
No Intervention
Arm Description
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation via helmet
Intervention Description
Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet
Primary Outcome Measure Information:
Title
Need for Endotracheal Intubation
Description
Number of patients requiring endotracheal intubation after application of helmet device
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Improvement in Oxygen Saturation
Description
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Time Frame
2 weeks
Title
Ventilator-free Days
Description
Duration of mechanical ventilation via endotracheal tube
Time Frame
28 days
Title
Intensive Care Unit Length of Stay
Description
Number of days admitted to intensive care unit
Time Frame
4 weeks
Title
Overall Mortality
Description
Death from any cause during hospitalization at time of enrollment
Time Frame
90 days
Title
Need for Proning
Description
Need for proning during the hospital stay
Time Frame
up to 24 weeks
Title
Intensive Care Unit Mortality
Description
Death from any cause during ICU hospitalization at time of enrollment
Time Frame
28 days
Title
Patient Tolerability
Description
the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance
Time Frame
28 days from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Z Peediyakkal, MD
Phone
0097450742399
Email
MPeediyakkal2@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulqadir J Nashwan, MSc
Phone
0097466473549
Email
anashwan@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Y Khatib, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazm Mebaireek General Hospital (HMGH)
City
Doha
Country
Qatar
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulqadir J. Nashwan, MSc
Email
anashwan@hamad.qa
First Name & Middle Initial & Last Name & Degree
Ahmed S. Mohamed, BSc
Email
AMohamed52@hamad.qa
First Name & Middle Initial & Last Name & Degree
Mohamad Y Khatib, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Z Peediyakkal, MD
First Name & Middle Initial & Last Name & Degree
Moustafa S Elshafei, MD
First Name & Middle Initial & Last Name & Degree
Hani S Elzeer, MD
First Name & Middle Initial & Last Name & Degree
Dore C Ananthegowda, MD
First Name & Middle Initial & Last Name & Degree
Muhsen A Shahen, MD
First Name & Middle Initial & Last Name & Degree
Wael I Abdaljawad, MD
First Name & Middle Initial & Last Name & Degree
Karimulla S Shaik, MD
First Name & Middle Initial & Last Name & Degree
Nevin Kannappilly, MD
First Name & Middle Initial & Last Name & Degree
Ahmed S Mohamed, BSc
First Name & Middle Initial & Last Name & Degree
Ahmed A Soliman, BSc
First Name & Middle Initial & Last Name & Degree
Abdulqadir J Nashwan, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15166842
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. doi: 10.1097/00075198-200402000-00001.
Results Reference
background
PubMed Identifier
12441753
Citation
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.
Results Reference
background
PubMed Identifier
26903337
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.
Results Reference
background
PubMed Identifier
22797452
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.
Results Reference
background
PubMed Identifier
22926653
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. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25. Erratum In: Intensive Care Med. 2012 Oct;38(10):1731-2.
Results Reference
background
PubMed Identifier
3492876
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. doi: 10.2214/ajr.148.3.501.
Results Reference
background
PubMed Identifier
23709194
Citation
Hess DR. Noninvasive ventilation for acute respiratory failure. Respir Care. 2013 Jun;58(6):950-72. doi: 10.4187/respcare.02319.
Results Reference
background
PubMed Identifier
23054404
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.
Results Reference
background
PubMed Identifier
22318634
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.
Results Reference
background
PubMed Identifier
24215648
Citation
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.
Results Reference
background
PubMed Identifier
17133177
Citation
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.
Results Reference
background
PubMed Identifier
14982647
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.
Results Reference
background
PubMed Identifier
27179847
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.
Results Reference
background
PubMed Identifier
33530249
Citation
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.
Results Reference
derived

Learn more about this trial

Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

We'll reach out to this number within 24 hrs