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Completed

NCT Number: NCT01680783

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive ventilation using a helmet hyperbaric device

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

Noninvasive ventilation via facemask

Other

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

Other names: mechanical ventilation

Primary outcomes

  1. Need for Endotracheal Intubation

    Time frame: 6 weeks

    Number of patients requiring endotracheal intubation after application of helmet device

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Duration of hospital stay

    Days spent in hospital at time of enrollment

  2. Number of Participants 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)

    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

    Time frame: number of days in the hospital

    Duration of mechanical ventilation via endotracheal tube

  4. Hospital Mortality

    Time frame: 90 days

    Death from any cause during hospitalization at time of enrollment

  5. Intensive Care Unit Length of Stay

    Time frame: 4 weeks

    Number of days admitted to a medical intensive care unit

Other outcomes

  1. ICU Complications

    Time frame: 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

    Time frame: 6 weeks

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

  3. Discharge Location

    Time frame: 6 weeks

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

  4. Improvement of Oxygenation

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2012
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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