Ventilatory Weaning Guided by a New Index

NCT04512677 | Completed

• 1 other identifier: Timed Inspiratory Effort Index
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiration, Artificial

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sucessful weaning

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

  Two years

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Mortality rate

  Two years

Study Arms (2)

No Interventions: Control

NO INTERVENTION

Conventional clinical treatment and using the ventilatory weaning protocol and standard extubation with the spontaneous breathing test (SBT) with the T-piece in 30 minutes.

Experimental: Intervention

EXPERIMENTAL

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

Device: Timed Inspiratory Effort (TIE index)

Interventions

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.

Experimental: Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (2)

Universidade Federal Fluminense

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

Hospital e Clínica São Gonçalo

São Gonçalo, Rio de Janeiro, Brazil

Location

Related Publications (11)

• 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. No abstract available.

  PMID: 28294658 BACKGROUND

• 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. doi: 10.1183/09031936.00010206.

  PMID: 17470624 RESULT

• de Souza LC, Guimaraes 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.

  PMID: 23753238 RESULT

• 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.

  PMID: 33332819 RESULT

• da Silva Guimaraes BL, de Souza LC, Guimaraes 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.

  PMID: 30914494 RESULT

• de Souza LC, Guimaraes 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.

  PMID: 25352688 RESULT

• Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange 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 Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.

  PMID: 27626706 RESULT

• Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.

  PMID: 31184740 RESULT

• 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. 2017 Jun 1;195(11):1477-1485. doi: 10.1164/rccm.201607-1338OC.

  PMID: 27768396 RESULT

• 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, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.

  PMID: 27762595 RESULT

• 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: 10.1007/s00134-015-4125-2. Epub 2015 Nov 16.

  PMID: 26572511 RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jecemir R Lugon, MD, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

• Marcos p Godoy, PT, MSc

  Hospital e Clínica São Gonçalo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The secret will be kept by the data collecting investigators and will only be revealed at the end of the data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: August 13, 2020
• Study Start: October 29, 2019
• Primary Completion: December 15, 2020
• Study Completion: January 10, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)