Muscle Pressure Estimation With Artificial Intelligence During Mechanical Ventilation

NCT05820347 | Completed

• 1 other identifier: CAAE: 59353422.9.0000.0068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. The main questions it aims to answer are: • Are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon? Participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; artificial intelligence

Outcome Measures

Primary Outcomes (3)

• Concordance between muscle pressure amplitude (in cmH2O) estimation by artificial intelligence and esophageal balloon

  Analysis of the bias and limits of agreement (Bland-Altman plot) between muscle pressure estimated amplitude in cmH2O from artificial intelligence and measured by esophageal balloon.

  4 hours

• Correlation between muscle pressure amplitude estimation (in cmH2O) by artificial intelligence and esophageal balloon

  Correlation, reported as R-squared and a correlation plot, between amplitude in cmH2O of muscle pressure estimation by artificial intelligence and esophageal balloon.

  4 hours

• Detection of initiation time and ending time of a spontaneous breathing cycle by artificial intelligence compared with esophageal balloon

  Time difference (in ms) between initiation of a spontaneous breathing cycle and ending of a spontaneous breathing cycle between artificial intelligence and esophageal balloon.

  4 hours

Secondary Outcomes (1)

• Sensitivity and specificity of patient-ventilator asynchrony automated detection using the Artificial Intelligence Muscle Pressure estimator

  4 hours

Study Arms (1)

Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation

OTHER

All included subjects will be monitored simultaneously with the esophageal balloon (gold standard) and with the artificial intelligence algorithm integrated in the mechanical ventilator. Electrical Impedance Tomography will be used to monitor ventilatory patterns during different degrees of spontaneous effort. First, a single intravenous bolus of neuromuscular blockade (succinylcholine 1mg/kg or rocuronium 1.2mg/kg) will be performed to measure respiratory system mechanics (compliance and resistance). In cases where rocuronium is used, a single dose of sugammadex 4mg/kg will be administered intravenously to reverse neuromuscular blockade after measuring compliance and resistance. After initiation of spontaneous breathing effort, pressure support will be titrated from 20 cmH2O to 2 cmH2O, in decremental steps during 20 minutes each. After completing titrating of pressure support, the esophageal balloon will be removed.

Device: Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation

Interventions

Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation DEVICE

Estimation of inspiratory muscle pressure by an artificial intelligence algorithm integrated in the mechanical ventilator (FlexiMag, Magnamed, Brazil).

Also known as: Esophageal balloon measurements of Muscle Pressure, Transient Neuromuscular Blockade with Succinylcholine or Rocuronium to measure Respiratory Mechanics, Electrical Impedance Tomography Monitorization

Artificial Intelligence Estimation of Muscle Pressure during Mechanical Ventilation

Eligibility Criteria

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

You may qualify if:

• Patients under assisted or assist-control mechanical ventilation

You may not qualify if:

• Contraindication to esophageal catheter insertion (esophageal cancer or bleeding, esophageal fistula, skull base fracture, uncontrolled coagulopathies)
• Contraindication to transient neuromuscular blockade
• Bronchopleural fistula (persistent air leak)
• Hemodynamic instability (norepinephrine \> 1mcg/kg/min)
• Gestation
• Current sinus infection
• Refusal from patient's family of attending physician
• Palliative care

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Magnamed Tecnologia Medica S/A: collaborator

Study Sites (1)

Heart Institute, University of São Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (15)

• Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.

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• Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.

  PMID: 24199628 BACKGROUND

• Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.

  PMID: 27002273 BACKGROUND

• Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC.

  PMID: 29323931 BACKGROUND

• Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.

  PMID: 29323536 BACKGROUND

• Sousa MLEA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Clusters of Double Triggering Impact Clinical Outcomes: Insights From the EPIdemiology of Patient-Ventilator aSYNChrony (EPISYNC) Cohort Study. Crit Care Med. 2021 Sep 1;49(9):1460-1469. doi: 10.1097/CCM.0000000000005029.

  PMID: 33883458 BACKGROUND

• Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21.

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• Pletsch-Assuncao R, Caleffi Pereira M, Ferreira JG, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Accuracy of Invasive and Noninvasive Parameters for Diagnosing Ventilatory Overassistance During Pressure Support Ventilation. Crit Care Med. 2018 Mar;46(3):411-417. doi: 10.1097/CCM.0000000000002871.

  PMID: 29189344 BACKGROUND

• Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.

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• Motta APG, Rigobello MCG, Silveira RCCP, Gimenes FRE. Nasogastric/nasoenteric tube-related adverse events: an integrative review. Rev Lat Am Enfermagem. 2021 Jan 8;29:e3400. doi: 10.1590/1518-8345.3355.3400. eCollection 2021.

  PMID: 33439952 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Eduardo LV Costa, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Marcelo BP Amato, MD, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 19, 2023
• Study Start: August 26, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)