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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680783
• Other study ID #: 12-1391
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: May 2016

Study information

• Verified date: July 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Cardiogenic Pulmonary Edema
• Hypoventilation
• Pulmonary Edema
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Shock
• Ventilatory Failure

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU Complications	ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness	6 weeks
Other	Readmission to the Intensive Care Unit	Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment	6 weeks
Other	Discharge Location	Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to	6 weeks
Other	Improvement of Oxygenation	Improvement of oxygenation-defined as PaO2/FiO2 = 200 or increase from baseline by 100	2 weeks
Primary	Need for Endotracheal Intubation	Number of patients requiring endotracheal intubation after application of helmet device	6 weeks
Secondary	Hospital Length of Stay	Days spent in hospital at time of enrollment	Duration of hospital stay
Secondary	Number of Participants Functional Status After Discharge	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)	Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)
Secondary	Ventilator-free Days	Duration of mechanical ventilation via endotracheal tube	number of days in the hospital
Secondary	Hospital Mortality	Death from any cause during hospitalization at time of enrollment	90 days
Secondary	Intensive Care Unit Length of Stay	Number of days admitted to a medical intensive care unit	4 weeks