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Ventilatory Weaning Guided by a New Index

Ventilatory Weaning Guided by the Timed Inspiratory Effort Index

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04512677
Enrollment
144
Registered
2020-08-13
Start date
2019-10-29
Completion date
2021-01-10
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration, Artificial

Keywords

Mechanical Ventilator, Ventilator Weaning, Spontaneous Breath Test, Predictive Index

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.

Interventions

DEVICETimed Inspiratory Effort (TIE index)

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

Sponsors

Universidade Federal Fluminense
Lead SponsorOTHER

Study design

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.

Intervention model description

Randomized controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Sucessful weaningTwo yearsCompare the timed inspiratory effort index parameter TIE as an indicator of weaning compared to the spontaneous breathing test

Secondary

MeasureTime frameDescription
Comparison of the length of stay in the ICUTwo yearsCompare 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.
Frequency of failure at weaningTwo yearsCompare the frequency of failure at weaning when using the TIE index or the T-piece TRE as a criterion for extubation.
Counting of the number of tests needed until extubationTwo yearsEvaluate the number of tests required until the decision favorable to extubation was made in both groups.

Other

MeasureTime frameDescription
Mortality rateTwo yearsCompare the ICU mortality among patients using the TIE or TRE method in T piece

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026