Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure

June 21, 2011 updated by: Hospital Clinic of Barcelona

A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure

The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

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

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital de Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clínic

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute hypercapnic respiratory failure.
  • Use of NIV to treat respiratory failure.
  • Persistence of hypercapnia after discontinuation of NIV

Exclusion Criteria:

  • Home NIV
  • Facial or cranial trauma or surgery,
  • Recent gastric or esophageal surgery,
  • Active upper gastrointestinal bleeding,
  • Excessive amount of respiratory secretions,
  • Tracheostomy
  • Lack of cooperation

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.
Device: Nocturnal non-invasive ventilation
Prolongation of non-invasive ventilation during 3 nights.
NO_INTERVENTION: 2
Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
Time Frame: At the end of enrollment time
At the end of enrollment time

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of long term dependency on non-invasive ventilation
Time Frame: At the end of enrollment time
At the end of enrollment time
Hospital and 6-month survival
Time Frame: At the end of enrollment time
At the end of enrollment time

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Jacobo Sellares, MD, Hospital Clínic

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

March 1, 2006

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (ESTIMATE)

October 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV-JS1

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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