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

Primary Purpose

Hypercapnic Respiratory Failure

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Nocturnal non-invasive ventilation

About this trial

This is an interventional supportive care trial for Hypercapnic Respiratory Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital del Mar
Hospital de Sant Pau
Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation

Secondary Outcome Measures

Incidence of long term dependency on non-invasive ventilation

Hospital and 6-month survival

Full Information

NCT ID

NCT00775710

First Posted

October 17, 2008

Last Updated

June 21, 2011

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT00775710

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Nocturnal non-invasive ventilation

Intervention Description

Prolongation of non-invasive ventilation during 3 nights.

Primary Outcome Measure Information:

Title

New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation

Time Frame

At the end of enrollment time

Secondary Outcome Measure Information:

Title

Incidence of long term dependency on non-invasive ventilation

Time Frame

At the end of enrollment time

Title

Hospital and 6-month survival

Time Frame

At the end of enrollment time

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacobo Sellares, MD

Organizational Affiliation

Hospital Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital de Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

28679605

Citation

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.

Results Reference

derived

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

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