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Clinical Trials/NCT00775710
NCT00775710CompletedPhase 4

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

Hospital Clinic of Barcelona3 sites in 1 country128 target enrollmentStarted: March 1, 2006Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
128
Locations
3
Primary Endpoint
New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
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

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

Arms & Interventions

1

Active Comparator

Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.

Intervention: Nocturnal non-invasive ventilation (Device)

2

No Intervention

Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night.

Outcomes

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(At the end of enrollment time)
  • Hospital and 6-month survival(At the end of enrollment time)

Investigators

Sponsor Class
Other

Study Sites (3)

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