Trial Outcomes & Findings for Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure (NCT NCT01680783)

Results Overview

Number of patients requiring endotracheal intubation after application of helmet device

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care 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	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 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.
Overall Study STARTED	39	44
Overall Study COMPLETED	39	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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 n=83 Participants Total of all reporting groups
Age, Continuous	60.9 years n=5 Participants	58 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of patients requiring endotracheal intubation after application of helmet device

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Need for Endotracheal Intubation	24 Participants	8 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay

Days spent in hospital at time of enrollment

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Hospital Length of Stay	15.2 days Interval 7.8 to 19.7	10.1 days Interval 6.5 to 15.9

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Number of Participants Functional Status After Discharge	6 Participants	22 Participants

SECONDARY outcome

Timeframe: number of days in the hospital

Duration of mechanical ventilation via endotracheal tube

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Ventilator-free Days	12.5 days Interval 0.49 to 28.0	28 days Interval 13.7 to 28.0

SECONDARY outcome

Timeframe: 90 days

Death from any cause during hospitalization at time of enrollment

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Hospital Mortality	19 Participants	12 Participants

SECONDARY outcome

Timeframe: 4 weeks

Number of days admitted to a medical intensive care unit

Outcome measures

Outcome measures
Measure	Usual Care n=39 Participants 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	Non Invasive Ventilation Via Helmet n=44 Participants 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.
Intensive Care Unit Length of Stay	7.8 days Interval 3.9 to 13.8	4.7 days Interval 2.5 to 8.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John P. Kress

University of Chicago

Phone: 7737026790

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place