Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in 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.

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Key information

Conditions

Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nocturnal non-invasive ventilation

Device

Prolongation of non-invasive ventilation during 3 nights.

Primary outcomes

New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation

Time frame: At the end of enrollment time

Secondary outcomes

Incidence of long term dependency on non-invasive ventilation

Time frame: At the end of enrollment time
Hospital and 6-month survival

Time frame: At the end of enrollment time

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Oct 20, 2008
Registry last updated: Jun 22, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed