Non-Invasive Ventilation After Extubation in Hypercapnic Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Noninvasive Ventilation After Extubation in Hypercapnic Patients

NCT01047852

Respiratory Failure

COMPLETED NA

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

NCT00775710

Hypercapnic Respiratory Failure

COMPLETED PHASE4

The Obesity-hypoventilation Syndrome Study of Clinical Characteristics and Predictive Factors of Response to Treatment

NCT00938977

Obesity Hypoventilation Syndrome

COMPLETED NA

Alternative of Treatment in Obesity Hypoventilation Syndrome

NCT01405976

Obesity Hypoventilation Syndrome

COMPLETED NA

Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients

NCT04125342

Extubation Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-invasive ventilation

Non-invasive ventilation after extubation for 24 hours

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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