Clinical trial NCT04512677: Ventilatory Weaning Guided by a New Index
Official title: Ventilatory Weaning Guided by the Timed Inspiratory Effort Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Keywords: Mechanical Ventilator
Ventilator Weaning
Spontaneous Breath Test
Predictive Index
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value.

Detailed description: Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value. Our study aimed to evaluate the performance of a new ventilatory weaning index, the timed inspiratory effort index (TIE index), as a weaning predictor in comparison with the traditionally used spontaneous breathing test (SBT). The study is a randomized controlled trial of a cohort of mechanically ventilated patients over 24 hours admitted to the ICU of Hospital e Clínica São Gonçalo (HCSG), located in the city of São Gonçalo, State of Rio de Janeiro, Brazil. The TIE index is calculated as the ratio of the maximum inspiratory pressure developed in the last 30 seconds of a 60 second period of unidirectional airway occlusion by the time required to reach this value.

Eligibility criteria: Inclusion and exclusion criteria

Our study included patients over 18 years old, under mechanical ventilation, who remained for more than 24 hours of invasive ventilatory assistance and who were able to start the process of weaning. Exclusion criteria comprised tracheostomy, chronic neurological disorders, low level of alertness, and chronic immune suppression states, including positive serology for HIV.

Primary outcomes:
measure: Sucessful weaning
timeFrame: Two years
Secondary outcomes:
measure: Frequency of failure at weaning
timeFrame: Two years
measure: Counting of the number of tests needed until extubation
timeFrame: Two years
measure: Comparison of the length of stay in the ICU
timeFrame: Two years
Other outcomes:
measure: Mortality rate
timeFrame: Two years
Locations:
city: Niterói
country: Brazil
facility: Universidade Federal Fluminense
state: Rio De Janeiro
city: São Gonçalo
country: Brazil
facility: Hospital e Clínica São Gonçalo
state: Rio De Janeiro
Study officials:
affiliation: Universidade Federal Fluminense
name: Jecemir R Lugon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital e Clínica São Gonçalo
name: Marcos p Godoy, PT, MSc
role: STUDY_CHAIR
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citation: da Silva Guimaraes B, de Souza LC, Cordeiro HF, Regis TL, Leite CA, Puga FP, Alvim SH, Lugon JR. Inspiratory Muscle Training With an Electronic Resistive Loading Device Improves Prolonged Weaning Outcomes in a Randomized Controlled Trial. Crit Care Med. 2021 Apr 1;49(4):589-597. doi: 10.1097/CCM.0000000000004787.
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