Clinical trial NCT01464567: Spontaneous Breathing Trials Using Pressure-Support or T-Tube in Chronic Obstructive Pulmonary Disease Patients Weaning Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weaning of Mechanical Ventilation
Chronic Obstructive Pulmonary Disease
Keywords: Weaning
Chronic Obstructive Pulmonary Disease
Spontaneous Breathing Trial
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Days Spent on Mechanical Ventilation
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Extubation success rate
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: RS
Study officials:
References:
citation: 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.