Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01680783
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome; Shock; Ventilatory Failure; Cardiogenic Pulmonary Edema	Device: Non invasive ventilation using a helmet hyperbaric device; Other: Noninvasive ventilation via facemask	N/A

Detailed Description

Respiratory failure is often treated with endotracheal intubation and mechanical ventilation. Although, the institution of mechanical ventilation is considered life saving, the associated complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and neuromuscular weakness are not without considerable morbidity and mortality.

Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory failure in immunocompromised patients.

Despite the advantages of non-invasive ventilation via facemask, some patients fail because of mask intolerance and severity of disease. Further limitation to facemask non-invasive ventilation is that the seal integrity is lost when higher pressures are required. Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock may require such higher pressures.

In an attempt to improve patient tolerability and deliver higher pressures, a transparent helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the entire head and neck of the patient. The design of the helmet confers some important advantages: 1) the transparency allows the patient to interact with the environment; 2) the lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems of leaking with higher airway pressures that are seen with the face mask; 4) it can be applied to any patient regardless of facial contour.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Usual Care Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.	Other: Noninvasive ventilation via facemask; Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask; Other Names: mechanical ventilation
Experimental: Non invasive ventilation via helmet Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure	Device: Non invasive ventilation using a helmet hyperbaric device; Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.; Other Names: Sea-Long medical treatment hood

Outcome Measures

Primary Outcome Measures

1. Need for Endotracheal Intubation [6 weeks]

   Number of patients requiring endotracheal intubation after application of helmet device

Secondary Outcome Measures

1. Hospital Length of Stay [Duration of hospital stay]

   Days spent in hospital at time of enrollment

2. Number of Participants Functional Status After Discharge [Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)]

   Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)

3. Ventilator-free Days [number of days in the hospital]

   Duration of mechanical ventilation via endotracheal tube

4. Hospital Mortality [90 days]

   Death from any cause during hospitalization at time of enrollment

5. Intensive Care Unit Length of Stay [4 weeks]

   Number of days admitted to a medical intensive care unit

Other Outcome Measures

1. ICU Complications [6 weeks]

   ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness

2. Readmission to the Intensive Care Unit [6 weeks]

   Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment

3. Discharge Location [6 weeks]

   Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to

4. Improvement of Oxygenation [2 weeks]

   Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged ≥18 years of age who require noninvasive ventilation via facemask for

8hours

• Intact airway protective gag reflex

• Able to follow instructions

Exclusion Criteria:

• Cardiopulmonary arrest

• Glasgow coma scale <8

• Absence of airway protective gag reflex

• Elevated intracranial pressure

• Tracheostomy

• Upper airway obstruction

• Pregnancy.

• Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: John P Kress, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01680783
• Other Study ID Numbers: 12-1391
• First Posted: Sep 7, 2012
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by University of Chicago: noninvasive ventilation; acute hypoxemic respiratory failure; Acute respiratory distress syndrome; shock
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Pulmonary Edema; Hypoventilation

Study Results

Participant Flow

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Period Title: Overall Study
STARTED	39	44
COMPLETED	39	44
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet	Total
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.	Total of all reporting groups
Overall Participants	39	44	83
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	60.9	58	59
Sex: Female, Male (Count of Participants)
Female	18 46.2%	20 45.5%	38 45.8%
Male	21 53.8%	24 54.5%	45 54.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.6%	2 4.5%	3 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	22 56.4%	28 63.6%	50 60.2%
White	16 41%	14 31.8%	30 36.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Count of Participants [Participants]	24 61.5%	8 18.2%

2. Secondary Outcome

Title	Hospital Length of Stay
Description	Days spent in hospital at time of enrollment
Time Frame	Duration of hospital stay

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Median (Inter-Quartile Range) [days]	15.2	10.1

3. Secondary Outcome

Title	Number of Participants Functional Status After Discharge
Description	Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
Time Frame	Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Count of Participants [Participants]	6 15.4%	22 50%

4. Secondary Outcome

Title	Ventilator-free Days
Description	Duration of mechanical ventilation via endotracheal tube
Time Frame	number of days in the hospital

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Median (Inter-Quartile Range) [days]	12.5	28

5. Secondary Outcome

Title	Hospital Mortality
Description	Death from any cause during hospitalization at time of enrollment
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Count of Participants [Participants]	19 48.7%	12 27.3%

6. Secondary Outcome

Title	Intensive Care Unit Length of Stay
Description	Number of days admitted to a medical intensive care unit
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask	Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Measure Participants	39	44
Median (Inter-Quartile Range) [days]	7.8	4.7

7. Other Pre-specified Outcome

Title	ICU Complications
Description	ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Readmission to the Intensive Care Unit
Description	Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Discharge Location
Description	Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Improvement of Oxygenation
Description	Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	Usual Care		Non Invasive Ventilation Via Helmet
Arm/Group Description	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask		Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
All Cause Mortality
	Usual Care		Non Invasive Ventilation Via Helmet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/39 (56.4%)		12/44 (27.3%)
Serious Adverse Events
	Usual Care		Non Invasive Ventilation Via Helmet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Non Invasive Ventilation Via Helmet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.