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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "T" Tube Spontaneous Breathing Trial | Active Comparator | Spontaneous Breathing Trial wuth "T" Tube for 30 minutes. |
|
| Pressure Support Ventilation | Experimental | Spontaneous Breathing Trial wuth Ventilation on Pressure-Support mode set at 10cmH2O for 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "T" Tube Spontaneous Breathing Trial | Procedure | "T" Tube ventilation for 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days Spent on Mechanical Ventilation | Participants will be followed for the duration of ICU stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora da Conceição | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil | ||
| Hospital Nossa Senhora da Conceição |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30138422 | Derived | 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. |
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| Pressure Support Ventilation | Procedure | Pressure-Support Ventilation for 30 minutes |
|
| Porto Alegre |
| Rio Grande do Sul |
| Brazil |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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