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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01680783
First received: August 29, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Acute Respiratory Distress Syndrome
Shock
Ventilatory Failure
Cardiogenic Pulmonary Edema
Device: Non invasive ventilation using a helmet hyperbaric device
Other: Noninvasive ventilation via facemask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Need for endotracheal intubation [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
    Percentage of patients requiring endotracheal intubation after application of helmet device

  • Intensive care unit length of stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of days admitted to a medical intensive care unit


Secondary Outcome Measures:
  • ICU complications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness

  • Hospital length of stay [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Days spent in hospital at time of enrollment

  • Readmission to the intensive care unit [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment

  • Discharge location [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to

  • Functional status after discharge [ 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) ] [ Designated as safety issue: No ]
    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)

  • Improvement of oxygenation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100

  • Ventilator days [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Duration of mechanical ventilation via endotracheal tube

  • Hospital mortality [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Death from any cause during hospitalization at time of enrollment


Estimated Enrollment: 622
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sea-Long medical treatment hood

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680783

Contacts
Contact: John P Kress, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu
Contact: Bhakti K Patel, MD 773-702-1740 bhakti.patel@uchospitals.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: John P Kress, MD    773-702-1740    jkress@medicine.bsd.uchicago.edu   
Contact: Bhakti K Patel, MD    773-702-1740    bhakti.patel@uchospitals.edu   
Principal Investigator: John P Kress, MD         
Sub-Investigator: Bhakti K Patel, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: John P Kress, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01680783     History of Changes
Other Study ID Numbers: 12-1391
Study First Received: August 29, 2012
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
noninvasive ventilation
acute hypoxemic respiratory failure
Acute respiratory distress syndrome
shock

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pulmonary Edema
Hypoventilation
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014