Noninvasive 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

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

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 (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

Related Clinical Trials

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

Non-Invasive Ventilation After Extubation in Hypercapnic Patients

NCT00539708

Respiratory Failure

COMPLETED NA

Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients

NCT04014920

Obesity Ventilation Intensive Care Unit

COMPLETED NA

Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation

NCT00977002

Extubation Failure Acute Respiratory Failure Post Extubation

UNKNOWN PHASE3

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

NCT00775710

Hypercapnic Respiratory Failure

COMPLETED PHASE4

Non Invasive Ventilation Combined to High Flow Nasal Cannula Oxygen for Preoxygenation of Hypoxemic ICU Patients

NCT02530957

Intubation Intraesophageal

COMPLETED NA

Detailed Description

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

Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age \> 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score \> 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

NIV

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type PROCEDURE

NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Noninvasive ventilation

NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Patients intubated for 48 hours or more
* Patients with Chronic respiratory disorders
* And/or hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria

* Face or cranial trauma or surgery
* Home noninvasive ventilation
* Recent gastric or oesophageal surgery
* Tracheostomy or other upper airway disorders
* Upper gastrointestinal bleeding
* Excess respiratory secretions
* Lack of collaboration
* Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No