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

This study has been completed.
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: October 17, 2008
Last updated: June 21, 2011
Last verified: October 2008

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

Condition Intervention Phase
Hypercapnic Respiratory Failure
Device: Nocturnal non-invasive ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure

Resource links provided by NLM:

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation [ Time Frame: At the end of enrollment time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of long term dependency on non-invasive ventilation [ Time Frame: At the end of enrollment time ] [ Designated as safety issue: No ]
  • Hospital and 6-month survival [ Time Frame: At the end of enrollment time ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: March 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00775710

Hospital Clinic
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Jacobo Sellares, MD Hospital Clinic
  More Information

No publications provided

Responsible Party: Dr. Jacobo Sellares, Respiratoy Intensive Care Unit Identifier: NCT00775710     History of Changes
Other Study ID Numbers: NIV-JS1
Study First Received: October 17, 2008
Last Updated: June 21, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases processed this record on April 17, 2014