Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients

NCT06494215 | Recruiting

• 1 other identifier: 79317924.0.0000.0068
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.

Conditions

Asynchrony, Patient-Ventilator; ARDS; Respiratory Insufficiency; Respiratory Effort-Related Arousal | Patient | Respiratory Measures and Ventilator Management

Keywords

Pendelluft; Ventilator-patient asynchrony; Patient self-induced lung injury; ARDS; Respiratory failure; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (3)

• 1. Magnitude of Pendelluft

  Three differents methods of estimating magnitude of Pendelluft shall be compared using a software based on electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil)

  During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

• 2. Magnitude of Pendelluft during inspiratory pause

  One of the methods of Pendelluft measurement shall be performed during an inspiratory pause for comparison with a normal cycle (without pause).

  During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

• 3. Magnitude of respiratory effort

  Respiratory effort shall be estimated through expiratory pauses and though recording of esophageal pressure at different pressure support levels. These data shall be compared to Pendelluft magnitude according to the different methods of calculation

  During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

Study Arms (1)

Pressure Support Variation

OTHER

Patients shall be submitted to pressure support variation in a randomly assigned manner. First 30 minutes after plethysmogram stabilization shall be recorded at clinical pressure support. Next, a blood gas sample shall be collected by a nurse or a physician, and three inspiratory pauses of at least 2 seconds shall be performed in between eight respiratory cycles. Next three expiratory pauses shall be performed in between eight respiratory cycles. All data shall be recorded and analysed offline. Subsequently the same sequence of events shall be performed at a 50% higher pressure support and at a 50% lower pressure support. The sequence in which this will happen shall be randomly assigned (first lower PS vs higher PS or first higher PS vs lower PS).

Other: Pressure Support Variation and Calculation of Respiratory Mechanics

Interventions

Pressure Support Variation and Calculation of Respiratory Mechanics OTHER

Patients will be submitted to different levels of pressure support (PS) in a randomly assigned order. First 30 minutes shall be recorded at the clinical PS. Next, blood gas samples shall be collected. Subsequently, three inspiratory pauses of at least 2 seconds shall be performed with an interval of at least 8 respiratory cycles between them. The same shall be performed with three expiratory pauses. Next, the PS shall be varied to 50% less or 50% more than clinical PS (based on randomization) and the same procedures shall be performed after 30 minutes of data recording (blood gas sample collection, inspiratory and expiratory pauses). All data shall be analyzed offline using a software that will be able to compare three different methods to calculate Pendelluft magnitude based on the literature. After completion of the protocol, ventilatory parameters shall be returned to the original settings. If the patient becomes tachypneic during lower PS, the protocol shall be interrupted.

Pressure Support Variation

Eligibility Criteria

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

You may qualify if:

• Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)

You may not qualify if:

• Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (16)

• Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.

  PMID: 11435237 BACKGROUND

• Sassoon CS, Zhu E, Caiozzo VJ. Assist-control mechanical ventilation attenuates ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Sep 15;170(6):626-32. doi: 10.1164/rccm.200401-042OC. Epub 2004 Jun 16.

  PMID: 15201132 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

• Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.

  PMID: 27786562 BACKGROUND

• 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

• Arellano DH, Brito R, Morais CCA, Ruiz-Rudolph P, Gajardo AIJ, Guinez DV, Lazo MT, Ramirez I, Rojas VA, Cerda MA, Medel JN, Illanes V, Estuardo NR, Bruhn AR, Brochard LJ, Amato MBP, Cornejo RA. Pendelluft in hypoxemic patients resuming spontaneous breathing: proportional modes versus pressure support ventilation. Ann Intensive Care. 2023 Dec 20;13(1):131. doi: 10.1186/s13613-023-01230-w.

  PMID: 38117367 BACKGROUND

• Bellani G, Grasselli G, Teggia-Droghi M, Mauri T, Coppadoro A, Brochard L, Pesenti A. Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study. Crit Care. 2016 Apr 28;20(1):142. doi: 10.1186/s13054-016-1290-9.

  PMID: 27160458 BACKGROUND

• Cornejo RA, Arellano DH, Ruiz-Rudolph P, Guinez DV, Morais CCA, Gajardo AIJ, Lazo MT, Brito RE, Cerda MA, Gonzalez SJ, Rojas VA, Diaz GA, Lopez LDM, Medel JN, Soto DI, Bruhn AR, Amato MBP, Estuardo NR. Inflammatory biomarkers and pendelluft magnitude in ards patients transitioning from controlled to partial support ventilation. Sci Rep. 2022 Nov 23;12(1):20233. doi: 10.1038/s41598-022-24412-1.

  PMID: 36418386 BACKGROUND

• Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

  PMID: 27596161 BACKGROUND

• Su PL, Zhao Z, Ko YF, Chen CW, Cheng KS. Spontaneous Breathing and Pendelluft in Patients with Acute Lung Injury: A Narrative Review. J Clin Med. 2022 Dec 15;11(24):7449. doi: 10.3390/jcm11247449.

  PMID: 36556064 BACKGROUND

• Coppadoro A, Grassi A, Giovannoni C, Rabboni F, Eronia N, Bronco A, Foti G, Fumagalli R, Bellani G. Occurrence of pendelluft under pressure support ventilation in patients who failed a spontaneous breathing trial: an observational study. Ann Intensive Care. 2020 Apr 7;10(1):39. doi: 10.1186/s13613-020-00654-y.

  PMID: 32266600 BACKGROUND

• Sang L, Zhao Z, Yun PJ, Frerichs I, Moller K, Fu F, Liu X, Zhong N, Li Y. Qualitative and quantitative assessment of pendelluft: a simple method based on electrical impedance tomography. Ann Transl Med. 2020 Oct;8(19):1216. doi: 10.21037/atm-20-4182.

  PMID: 33178748 BACKGROUND

• Chi Y, Zhao Z, Frerichs I, Long Y, He H. Prevalence and prognosis of respiratory pendelluft phenomenon in mechanically ventilated ICU patients with acute respiratory failure: a retrospective cohort study. Ann Intensive Care. 2022 Mar 5;12(1):22. doi: 10.1186/s13613-022-00995-w.

  PMID: 35246748 BACKGROUND

• Bellani G, Grassi A, Sosio S, Gatti S, Kavanagh BP, Pesenti A, Foti G. Driving Pressure Is Associated with Outcome during Assisted Ventilation in Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Sep;131(3):594-604. doi: 10.1097/ALN.0000000000002846.

  PMID: 31335543 BACKGROUND

• Bellani G, Grassi A, Sosio S, Foti G. Plateau and driving pressure in the presence of spontaneous breathing. Intensive Care Med. 2019 Jan;45(1):97-98. doi: 10.1007/s00134-018-5311-9. Epub 2018 Jul 13. No abstract available.

  PMID: 30006893 BACKGROUND

• Bastia L, Amendolagine L, Pozzi F, Carenini S, Cipolla C, Curto F, Bellani G, Fumagalli R, Chieregato A. Reliability of Respiratory System Compliance Calculation During Assisted Mechanical Ventilation: A Retrospective Study. Crit Care Med. 2023 Oct 1;51(10):e201-e205. doi: 10.1097/CCM.0000000000005964. Epub 2023 Jun 16.

  PMID: 37326475 BACKGROUND

MeSH Terms

Conditions

Patient-Ventilator Asynchrony; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcelo BP Amato

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo BP Amato, MD PhD

CONTACT

3061-7361; marcelo.amato@hc.fm.usp.br

Emily Sofia Ceron

CONTACT

+5511967259925; emily.s.ceron11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the participants shall be exposed to the same situations (variation of pressure support and inspiratory/expiratory pauses)

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: June 11, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)