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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00775710
First received: October 17, 2008
Last updated: June 21, 2011
Last verified: October 2008
  Purpose

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775710

Locations
Spain
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
Investigators
Principal Investigator: Jacobo Sellares, MD Hospital Clinic
  More Information

No publications provided

Responsible Party: Dr. Jacobo Sellares, Respiratoy Intensive Care Unit
ClinicalTrials.gov 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:
Hypercapnia
Hypoventilation
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014