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Non-Invasive Ventilation After Extubation in Hypercapnic Patients

NCT ID: NCT00539708

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients. Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 \>45 mmHg) during the spontaneous breathing trial, ready to be extubated. Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management. Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay). Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).

Conditions

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Respiratory Failure

Keywords

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Non-invasive ventilation Hypercapnic respiratory failure Mechanical ventilation Respiratory failure after extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NIV

Non-invasive ventilation

Group Type EXPERIMENTAL

Non-invasive ventilation

Intervention Type PROCEDURE

Non-invasive ventilation after extubation for 24 hours

Control

Oxygen therapy

Group Type ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type PROCEDURE

Non-invasive ventilation after extubation for 24 hours

Interventions

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Non-invasive ventilation

Non-invasive ventilation after extubation for 24 hours

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic of Barcelona

Principal Investigators

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Miquel Ferrer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 19682735 (View on PubMed)

Other Identifiers

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FIS 041130

Identifier Type: -

Identifier Source: org_study_id