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Clinical Trials/NCT04512677
NCT04512677CompletedNot Applicable

Ventilatory Weaning Guided by the Timed Inspiratory Effort Index

Universidade Federal Fluminense3 sites in 1 country144 target enrollmentStarted: October 29, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
3
Primary Endpoint
Sucessful weaning

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

The secret will be kept by the data collecting investigators and will only be revealed at the end of the data analysis.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sucessful weaning

Time Frame: Two years

Compare the timed inspiratory effort index parameter TIE as an indicator of weaning compared to the spontaneous breathing test

Secondary Outcomes

  • Frequency of failure at weaning(Two years)
  • Counting of the number of tests needed until extubation(Two years)
  • Comparison of the length of stay in the ICU(Two years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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