Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Comparison Between Spontaneous Breathing Trials Through Pressure-Support Ventilation or "T" Tube in the Weaning of Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464567
• Other study ID #: TVEDPOC-001
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2011
• Last updated: November 23, 2016
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Hospital Nossa Senhora da Conceicao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Weaning of mechanical ventilation (MV) is an essential part in management of patients with Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be used has not been established.

Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation with SBT through "T" tube in weaning of MV in patients with COPD.

Design: Randomized Clinical Trial. Methods: This study will include patients with COPD, admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for at least 48 hours. When considered by the care team ready for SBT, they will be randomized to one of the following strategies: SBT in Pressure Support or SBT through "T" Tube. The primary endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and incidence of tracheostomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD patients admitted to our ICU for Acute Respiratory Failure, submitted to Mechanical Ventilation for at least 48 hours

• 18 years or older

Exclusion Criteria:

• Tracheostomy

• Younger than 18 years

• Refuse to give informed consent

• Individuals who are already enrolled in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration
• Weaning of Mechanical Ventilation

Intervention

Procedure:
• "T" Tube Spontaneous Breathing Trial
"T" Tube ventilation for 30 minutes
• Pressure Support Ventilation
Pressure-Support Ventilation for 30 minutes

Locations

Country	Name	City	State
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre	Rio Grande do Sul
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days Spent on Mechanical Ventilation		Participants will be followed for the duration of ICU stay, an expected average of 2 weeks	No
Secondary	Mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Extubation success rate		Participants will be followed for the duration of ICU stay, an expected average of 4 weeks	No