Prediction of Inspiratory Effort Response to High PEEP in Patients Recovering From ARDS

NCT04524091 | Recruiting

• 1 other identifier: 20.2020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous breathing during the transition from controlled to assisted ventilation in ARDS may be harmful, as high respiratory drive can generate large transpulmonary pressure swings and worsen lung injury. Higher PEEP may mitigate this by reducing inspiratory effort and lung stress, but patient response is variable and difficult to predict. While improved lung compliance appears to mediate the protective effects of PEEP, its bedside assessment is complex. Preclinical data suggest that changes in compliance are inversely reflected by changes in respiratory rate, but this relationship and its clinical utility in ARDS patients remain unclear.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Lung compliance response

  changes in lung compliance from one PEEP level to the subsequent higher level, expressed in percentage of change

  10 minutes

Secondary Outcomes (3)

• Esophageal pressure swing

  10 minutes

• Dynamic transpulmonary pressure swing

  10 minutes

• Respiratory rate response

  10 minutes

Interventions

Positive end expiratory pressure OTHER

Initially, the patients will be ventilated using pressure support ventilation with an inspiratory pressure adjusted to achieve 6 - 8 ml/kg of PBW with a minimal esophageal pressure swing of 5 cmH2O and a PEEP of 5 cmH2O. After 5 minutes, we will collect basic and advanced respiratory monitoring, including esophageal pressure and transpulmonary pressure swings. The same procedure will be carried out with 10 and 15 cmH2O of PEEP. Inspiratory pressure will be kept constant throughout the protocol.

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 with acute respiratory distress syndrome ventilated using an endotracheal tube admitted to Anchorena San Martin intensive care unit who are ventilated in pressure support ventilation.

You may qualify if:

• Need of invasive mechanical ventilation
• Patients who had fulfill ARDS criteria based on Berlin definition during any time of invasive mechanical ventilation.
• Patient ventilated in pressure support ventilation.
• Time of invasive ventilation expected to be longer than 24 hs after the day of enrollment.

You may not qualify if:

• Neuromuscular diseases (e.g., amyotrophic lateral sclerosis, Duchenne Erb)
• previous diagnosis of chronic obstructed pulmonary disease
• not resolved pneumothorax
• bronchopleural fistula
• suspicion of central respiratory drive alteration (e.g., benzodiazepines intoxication).

Sponsors & Collaborators

• Sanatorio Anchorena San Martin: lead

Study Sites (1)

Sanatorio Anchorena de San Martin

San Martín, Buenos Aires, B1650CQU, Argentina

RECRUITING

Related Publications (10)

• 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

• DAS-Taskforce 2015; Baron R, Binder A, Biniek R, Braune S, Buerkle H, Dall P, Demirakca S, Eckardt R, Eggers V, Eichler I, Fietze I, Freys S, Frund A, Garten L, Gohrbandt B, Harth I, Hartl W, Heppner HJ, Horter J, Huth R, Janssens U, Jungk C, Kaeuper KM, Kessler P, Kleinschmidt S, Kochanek M, Kumpf M, Meiser A, Mueller A, Orth M, Putensen C, Roth B, Schaefer M, Schaefers R, Schellongowski P, Schindler M, Schmitt R, Scholz J, Schroeder S, Schwarzmann G, Spies C, Stingele R, Tonner P, Trieschmann U, Tryba M, Wappler F, Waydhas C, Weiss B, Weisshaar G. Evidence and consensus based guideline for the management of delirium, analgesia, and sedation in intensive care medicine. Revision 2015 (DAS-Guideline 2015) - short version. Ger Med Sci. 2015 Nov 12;13:Doc19. doi: 10.3205/000223. eCollection 2015.

  PMID: 26609286 BACKGROUND

• Schepens T, Dres M, Heunks L, Goligher EC. Diaphragm-protective mechanical ventilation. Curr Opin Crit Care. 2019 Feb;25(1):77-85. doi: 10.1097/MCC.0000000000000578.

  PMID: 30531536 BACKGROUND

• Mauri T, Cambiaghi B, Spinelli E, Langer T, Grasselli G. Spontaneous breathing: a double-edged sword to handle with care. Ann Transl Med. 2017 Jul;5(14):292. doi: 10.21037/atm.2017.06.55.

  PMID: 28828367 BACKGROUND

• Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

  PMID: 26167730 BACKGROUND

• Telias I, Brochard L, Goligher EC. Is my patient's respiratory drive (too) high? Intensive Care Med. 2018 Nov;44(11):1936-1939. doi: 10.1007/s00134-018-5091-2. Epub 2018 Mar 1. No abstract available.

  PMID: 29497778 BACKGROUND

• Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.

  PMID: 27626833 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

• Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.

  PMID: 22430241 BACKGROUND

• Mauri T, Bellani G, Confalonieri A, Tagliabue P, Turella M, Coppadoro A, Citerio G, Patroniti N, Pesenti A. Topographic distribution of tidal ventilation in acute respiratory distress syndrome: effects of positive end-expiratory pressure and pressure support. Crit Care Med. 2013 Jul;41(7):1664-73. doi: 10.1097/CCM.0b013e318287f6e7.

  PMID: 23507723 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Joaquin Pérez, PT

CONTACT

+542245505907; licjoaquinperez@hotmail.com

Javier H Dorado, PT

CONTACT

+54 1141644262; javierhdorado@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of physica therapy department

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: August 1, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

AR (1)