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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775710

Enrollment

128

Registered

2008-10-20

Start date

2006-03-31

Completion date

2010-08-31

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Respiratory Failure

Brief summary

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

Interventions

DEVICENocturnal non-invasive ventilation

Prolongation of non-invasive ventilation during 3 nights.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026