NCT00539708

Brief Summary

The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

2.7 years

First QC Date

October 3, 2007

Last Update Submit

May 6, 2008

Conditions

Respiratory Failure

Keywords

Non-invasive ventilationHypercapnic respiratory failureMechanical ventilationRespiratory failure after extubation

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: The incidence of respiratory failure after extubation

    3 days after extubation

Secondary Outcomes (1)

  • Survival

    90 days

Study Arms (2)

NIV

EXPERIMENTAL

Non-invasive ventilation

Procedure: Non-invasive ventilation

Control

ACTIVE COMPARATOR

Oxygen therapy

Procedure: Non-invasive ventilation

Interventions

Non-invasive ventilationPROCEDURE

Non-invasive ventilation after extubation for 24 hours

ControlNIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic respiratory disorders with invasive mechanical ventilation
  • Hypercapnic respiratory failure during successful spontaneous breathing trial

You may not qualify if:

  • Face or cranial trauma or surgery
  • Recent gastric or esophageal surgery
  • Tracheostomy or other upper airway disorders
  • Upper gastrointestinal bleeding
  • Excess respiratory secretions
  • Lack of collaboration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.

    PMID: 19682735DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Miquel Ferrer, MD, PhD

    UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

April 1, 2008

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

ES(1)