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Completed

NCT Number: NCT04512677

Ventilatory Weaning Guided by a New Index

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Timed Inspiratory Effort (TIE index)

Device

Conventional clinical treatment and using the Timed Inspiratory Effort (TIE index), which guided the decision to ventilate weaning and extubation.

Primary outcomes

  1. 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

  1. Frequency of failure at weaning

    Time frame: Two years

    Compare the frequency of failure at weaning when using the TIE index or the T-piece TRE as a criterion for extubation.

  2. Counting of the number of tests needed until extubation

    Time frame: Two years

    Evaluate the number of tests required until the decision favorable to extubation was made in both groups.

  3. Comparison of the length of stay in the ICU

    Time frame: Two years

    Compare the length of stay in the ICU between extubation, discharge or death counted from extubation among patients who used the TIE or SBT index in T piece.

Other outcomes

  1. Mortality rate

    Time frame: Two years

    Compare the ICU mortality among patients using the TIE or TRE method in T piece

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

Ventilatory Weaning Guided by the Timed Inspiratory Effort Index

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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