Non-Invasive Ventilation After Extubation in Hypercapnic... | NCT00539708

Studies
Non-Invasive Ventilation After Extubation in Hypercapnic Patients

NCT00539708

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

May 12, 2008Estimated

Enrollment

106Actual

Phase

Not Applicable

Conditions

Respiratory Failure

Interventions

Non-invasive ventilation

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Oct 3, 2007

First Submission Date that Met QC Criteria

Oct 3, 2007

First Posted Date

Oct 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2008

Last Update Posted Date

May 12, 2008Estimated

Name	Class
Fondo de Investigacion Sanitaria	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIV	Experimental	Non-invasive ventilation	Procedure: Non-invasive ventilation
Control	Active Comparator	Oxygen therapy	Procedure: Non-invasive ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive ventilation	Procedure	Non-invasive ventilation after extubation for 24 hours	Control NIV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome: The incidence of respiratory failure after extubation		3 days after extubation

Secondary Outcomes

Measure	Description	Time Frame
Survival		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miquel Ferrer, MD, PhD	UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona		08036	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19682735	Derived	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy