Ventilatory Weaning Guided by a New Index

Respiration, Artificial Clinical Trial

Official title:

Ventilatory Weaning Guided by the Timed Inspiratory Effort Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512677
• Other study ID #: Timed Inspiratory Effort Index
• Status: Completed
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: January 10, 2021

Study information

• Verified date: August 2021
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 10, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiration, Artificial

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal Fluminense	Niterói	Rio De Janeiro
Brazil	Hospital e Clínica São Gonçalo	São Gonçalo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

Béduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grangé S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definitio — View Citation

Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. — View Citation

da Silva Guimarães 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. 2 — View Citation

da Silva Guimarães BL, de Souza LC, Guimarães FS, Lugon JR. Serial Weekly Measurements of the Timed Inspiratory Effort Index Can Predict Successful Prolonged Weaning. Respir Care. 2019 Oct;64(10):1286-1292. doi: 10.4187/respcare.06367. Epub 2019 Mar 26. — View Citation

de Souza LC, Guimarães FS, Lugon JR. Evaluation of a new index of mechanical ventilation weaning: the timed inspiratory effort. J Intensive Care Med. 2015 Jan;30(1):37-43. doi: 10.1177/0885066613483265. Epub 2013 Apr 10. — View Citation

de Souza LC, Guimarães FS, Lugon JR. The timed inspiratory effort: a promising index of mechanical ventilation weaning for patients with neurologic or neuromuscular diseases. Respir Care. 2015 Feb;60(2):231-8. doi: 10.4187/respcare.03393. Epub 2014 Oct 28 — View Citation

Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strøm T, Wilson KC, Morris PE; ATS/C — View Citation

Jung B, Moury PH, Mahul M, de Jong A, Galia F, Prades A, Albaladejo P, Chanques G, Molinari N, Jaber S. Diaphragmatic dysfunction in patients with ICU-acquired weakness and its impact on extubation failure. Intensive Care Med. 2016 May;42(5):853-861. doi: — View Citation

MacIntyre N. Another Look at Outcomes from Mechanical Ventilation. Am J Respir Crit Care Med. 2017 Mar 15;195(6):710-711. doi: 10.1164/rccm.201610-1988ED. — View Citation

Sklar MC, Burns K, Rittayamai N, Lanys A, Rauseo M, Chen L, Dres M, Chen GQ, Goligher EC, Adhikari NKJ, Brochard L, Friedrich JO. Effort to Breathe with Various Spontaneous Breathing Trial Techniques. A Physiologic Meta-analysis. Am J Respir Crit Care Med — View Citation

Subirà C, Hernández G, Vázquez A, Rodríguez-García R, González-Castro A, García C, Rubio O, Ventura L, López A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sánchez C, Tizón A, Tenza E, Laborda C, Cabañes S, Lacueva V, Del Mar Fernández M, Arnau A, Fern — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality rate	Compare the ICU mortality among patients using the TIE or TRE method in T piece	Two years
Primary	Sucessful weaning	Compare the timed inspiratory effort index parameter TIE as an indicator of weaning compared to the spontaneous breathing test	Two years
Secondary	Frequency of failure at weaning	Compare the frequency of failure at weaning when using the TIE index or the T-piece TRE as a criterion for extubation.	Two years
Secondary	Counting of the number of tests needed until extubation	Evaluate the number of tests required until the decision favorable to extubation was made in both groups.	Two years
Secondary	Comparison of the length of stay in the ICU	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.	Two years