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

NCT ID: NCT01464567

Last Updated: 2016-11-25

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weaning of Mechanical Ventilation Chronic Obstructive Pulmonary Disease

Keywords

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Weaning Chronic Obstructive Pulmonary Disease Spontaneous Breathing Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"T" Tube Spontaneous Breathing Trial

Spontaneous Breathing Trial wuth "T" Tube for 30 minutes.

Group Type ACTIVE_COMPARATOR

"T" Tube Spontaneous Breathing Trial

Intervention Type PROCEDURE

"T" Tube ventilation for 30 minutes

Pressure Support Ventilation

Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes

Group Type EXPERIMENTAL

Pressure Support Ventilation

Intervention Type PROCEDURE

Pressure-Support Ventilation for 30 minutes

Interventions

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"T" Tube Spontaneous Breathing Trial

"T" Tube ventilation for 30 minutes

Intervention Type PROCEDURE

Pressure Support Ventilation

Pressure-Support Ventilation for 30 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role lead

Responsible Party

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Jose Augusto Santos Pellegrini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Santos Pellegrini JA, Boniatti MM, Boniatti VC, Zigiotto C, Viana MV, Nedel WL, Marques LDS, Dos Santos MC, de Almeida CB, Dal' Pizzol CP, Ziegelmann PK, Rios Vieira SR. Pressure-support ventilation or T-piece spontaneous breathing trials for patients with chronic obstructive pulmonary disease - A randomized controlled trial. PLoS One. 2018 Aug 23;13(8):e0202404. doi: 10.1371/journal.pone.0202404. eCollection 2018.

Reference Type DERIVED
PMID: 30138422 (View on PubMed)

Other Identifiers

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TVEDPOC-001

Identifier Type: -

Identifier Source: org_study_id