Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure

NCT06040138 | Recruiting

• 1 other identifier: 6810
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Mechanical ventilation is essential in the management of patients in Intensive Care. The approach to patients with prolonged weaning is challenging.In this context, it is vital to implement "diaphragmatic protection" strategies, which consist of programming the level of ventilator assistance focused on sustaining the muscular effort within an objective range. The reference method for measuring inspiratory effort is the Pressure-Time Product (PTP) of the esophagus. Recently, Bertoni et al. proposed the measurement of Occlusion Pressure as a non-invasive method, without the need to assess esophageal pressure, to estimate the magnitude of the effort and program assistance. Although it is a validated measurement for quantifying effort, it does not consider the duration of the effort performed by the patient, as well as the respiratory rate, two fundamental variables in terms of tolerance to the load. Therefore, the investigators propose the following study that will seek to validate the measurement of PTP in from the Occlusion Pressure, but considering inspiratory time and respiratory rate to obtain PTP per breath and per minute.

Conditions

Respiratory Failure; Weaning Failure

Keywords

mechanical ventilation; weaning; breathing effort; occlusion pressure; pressure time product; pressure support ventilation

Outcome Measures

Primary Outcomes (1)

• Airway Occlusion Pressure

  An inspiratory pressure will be set to obtain a muscular pressure value of 8 to 12 cmH2O. This phase will be called PSV100%. After 15 minutes, the level of assistance will be modified by 50%, up or down, according to the result of the randomization, and vice versa, always considering the initial value. Each of these phases will be called PSV150% and PSV50% respectively, and will last 15 minutes. During the last 3 minutes, 3 end-expiratory occlusion at a rate of 1 maneuver per minute will be performed, in order to obtain the airway Occlusion Pressure.

  At the end of the study, estimated in July 2024

Secondary Outcomes (1)

• Esophageal Pressure Time product per breath (PTPESOF-br) and per minute (PTPESOF-min)

  At the end of the study, estimated in July 2024

Study Arms (1)

Patients with prolonged weaning

Patients who have failed more than 3 spontaneous breathing trials, in pressure support ventilation, with hemodynamic and metabolic stability, and a regular and stable ventilatory pattern.

Diagnostic Test: End expiratory occlusion maneuver

Interventions

End expiratory occlusion maneuver DIAGNOSTIC_TEST

An end expiratory occlusion maneuver will be performed during pressure support ventilation in patients with prolonged weaning.

Patients with prolonged weaning

Eligibility Criteria

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

Study Population

Patients over 18 years of age with prolonged weaning from mechanical ventilation, who are in the intensive care units of the following hospitals: Hospital Italiano, Hospital Británico, Centro de Educación Médica e Investigaciones Clínicas 'Norberto Quirno' and Sanatorio Anchorena de San Martín, will be included

You may qualify if:

• Patients with mechanical ventilation, who failed 3 or more spontaneous breathing trials
• Esophageal balloon placed
• Who can trigger the ventilator
• With hemodynamic stability
• with P/F ratio above 150

You may not qualify if:

• under 18 years old of age
• pregnancy
• do not resuscitate order or expected poor short term prognosis
• refuse to sign the informed consent

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• HOSPITAL BRITANICO DE BUENOS AIRES: collaborator
• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: collaborator
• Sanatorio Anchorena San Martin: collaborator

Study Sites (4)

Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

Buenos Aires, Argentina

RECRUITING

Hospital Británico

Buenos Aires, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Sanatorio Anchorena San Martín

Buenos Aires, Argentina

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.

  PMID: 31694692 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 BACKGROUND

• Brault C, Mancebo J, Suarez Montero JC, Bentall T, Burns KEA, Piraino T, Lellouche F, Bouchard PA, Charbonney E, Carteaux G, Maraffi T, Beduneau G, Mercat A, Skrobik Y, Zuo F, Lafreniere-Roula M, Thorpe K, Brochard L, Bosma KJ. The PROMIZING trial enrollment algorithm for early identification of patients ready for unassisted breathing. Crit Care. 2022 Jun 23;26(1):188. doi: 10.1186/s13054-022-04063-4.

  PMID: 35739553 BACKGROUND

• Brochard L, Martin GS, Blanch L, Pelosi P, Belda FJ, Jubran A, Gattinoni L, Mancebo J, Ranieri VM, Richard JC, Gommers D, Vieillard-Baron A, Pesenti A, Jaber S, Stenqvist O, Vincent JL. Clinical review: Respiratory monitoring in the ICU - a consensus of 16. Crit Care. 2012 Dec 12;16(2):219. doi: 10.1186/cc11146.

  PMID: 22546221 BACKGROUND

• Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.

  PMID: 3988680 BACKGROUND

• Combes A, Costa MA, Trouillet JL, Baudot J, Mokhtari M, Gibert C, Chastre J. Morbidity, mortality, and quality-of-life outcomes of patients requiring >or=14 days of mechanical ventilation. Crit Care Med. 2003 May;31(5):1373-81. doi: 10.1097/01.CCM.0000065188.87029.C3.

  PMID: 12771605 BACKGROUND

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 BACKGROUND

• Dianti J, Fard S, Wong J, Chan TCY, Del Sorbo L, Fan E, Amato MBP, Granton J, Burry L, Reid WD, Zhang B, Ratano D, Keshavjee S, Slutsky AS, Brochard LJ, Ferguson ND, Goligher EC. Strategies for lung- and diaphragm-protective ventilation in acute hypoxemic respiratory failure: a physiological trial. Crit Care. 2022 Aug 29;26(1):259. doi: 10.1186/s13054-022-04123-9.

  PMID: 36038890 BACKGROUND

• Dorado JH, Navarro E, Plotnikow GA, Gogniat E, Accoce M; EpVAr Study Group. Epidemiology of Weaning From Invasive Mechanical Ventilation in Subjects With COVID-19. Respir Care. 2023 Jan;68(1):101-109. doi: 10.4187/respcare.09925. Epub 2022 Nov 15.

  PMID: 36379638 BACKGROUND

• Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.

  PMID: 23631814 BACKGROUND

• Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.

  PMID: 32516052 BACKGROUND

• Jonkman AH, Rauseo M, Carteaux G, Telias I, Sklar MC, Heunks L, Brochard LJ. Proportional modes of ventilation: technology to assist physiology. Intensive Care Med. 2020 Dec;46(12):2301-2313. doi: 10.1007/s00134-020-06206-z. Epub 2020 Aug 11.

  PMID: 32780167 BACKGROUND

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

  PMID: 10816184 BACKGROUND

• Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

  PMID: 27334266 BACKGROUND

• Penuelas O, Muriel A, Abraira V, Frutos-Vivar F, Mancebo J, Raymondos K, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Ferguson ND, Del Carmen Marin M, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Amin P, Cakar N, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Esteban A. Inter-country variability over time in the mortality of mechanically ventilated patients. Intensive Care Med. 2020 Mar;46(3):444-453. doi: 10.1007/s00134-019-05867-9. Epub 2020 Jan 7.

  PMID: 31912203 BACKGROUND

• Su PL, Kao PS, Lin WC, Su PF, Chen CW. Limited predictability of maximal muscular pressure using the difference between peak airway pressure and positive end-expiratory pressure during proportional assist ventilation (PAV). Crit Care. 2016 Nov 27;20(1):382. doi: 10.1186/s13054-016-1554-4.

  PMID: 27888836 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Emilio Steinberg, RT

  Hospital Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Steinberg, RT

CONTACT

+11 64977663; emilio.steinberg@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 15, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4)