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

NCT ID: NCT00775710

Last Updated: 2011-06-22

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

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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Conditions

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Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Nocturnal non-invasive ventilation

Intervention Type DEVICE

Prolongation of non-invasive ventilation during 3 nights.

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nocturnal non-invasive ventilation

Prolongation of non-invasive ventilation during 3 nights.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Respiratoy Intensive Care Unit

Principal Investigators

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Jacobo Sellares, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

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Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Sellares J, Ferrer M, Anton A, Loureiro H, Bencosme C, Alonso R, Martinez-Olondris P, Sayas J, Penacoba P, Torres A. Discontinuing noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations: a randomised controlled trial. Eur Respir J. 2017 Jul 5;50(1):1601448. doi: 10.1183/13993003.01448-2016. Print 2017 Jul.

Reference Type DERIVED
PMID: 28679605 (View on PubMed)

Other Identifiers

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NIV-JS1

Identifier Type: -

Identifier Source: org_study_id

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