NCT01464567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

4.3 years

First QC Date

October 24, 2011

Last Update Submit

November 23, 2016

Conditions

Weaning of Mechanical VentilationChronic Obstructive Pulmonary Disease

Keywords

WeaningChronic Obstructive Pulmonary DiseaseSpontaneous Breathing Trial

Outcome Measures

Primary Outcomes (1)

  • Days Spent on Mechanical Ventilation

    Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

Secondary Outcomes (2)

  • Mortality

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Extubation success rate

    Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Study Arms (2)

"T" Tube Spontaneous Breathing Trial

ACTIVE COMPARATOR

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

Procedure: "T" Tube Spontaneous Breathing Trial

Pressure Support Ventilation

EXPERIMENTAL

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

Procedure: Pressure Support Ventilation

Interventions

"T" Tube Spontaneous Breathing TrialPROCEDURE

"T" Tube ventilation for 30 minutes

"T" Tube Spontaneous Breathing Trial
Pressure Support VentilationPROCEDURE

Pressure-Support Ventilation for 30 minutes

Pressure Support Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Tracheostomy
  • Younger than 18 years
  • Refuse to give informed consent
  • Individuals who are already enrolled in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 30138422DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2011

First Posted

November 3, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

BR(2)