Helmet Ventilation in Acute Hypercapnic Respiratory Failure

October 5, 2014 updated by: dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"

Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.

In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40185
        • Sant'Orsola Malpighi
      • Bologna, Italy, 40185
        • sant'orsola malpighi hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pH < 7,35 and PaCO2 > 45 mmHg
  • respiratory rate > 20 b/min

Exclusion Criteria:

  • hypoxic respiratory failure
  • coma
  • inability to stand NIV
  • lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helmet to deliver NIV
Device: Helmet (Starmed)
The helmet is a kind of interface similar to a hood to deliver NIV
Other Names:
  • Starmed Helmet
Active Comparator: Total Face to deliver NIV
Device: Total Face mask (Respironics)
The total face mask is the "classical" interface for NIV delivery
Other Names:
  • Respironics Performax or similar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arterial Blood gases
Time Frame: at 1 hour after the start of NIV
at 1 hour after the start of NIV

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial Blood Gases
Time Frame: Once a day at 8 am until discharge
Once a day at 8 am until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 5, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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