Inspiratory Effort at Different Expiratory Cycling and Airway Resistance During Pressure Support Ventilation (CYCLOPES)

NCT05952726 | Completed

• 1 other identifier: CYCLOPES
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective interventional crossover randomized physiological study is to investigate the reliability of Pressure Muscle Index (PMI) - as an estimation of inspiratory effort - at different levels of expiratory cycling during pressure support ventilation. PMI will be compared with the esophageal pressure swing that is considered the gold standard technique. This study aims to answer to the following questions:

• which is the optimal expiratory cycling threshold where PMI better correlates with the esophageal pressure swing?
• what is the optimal correlation between the occlusion pressure (Poc) estimated by an expiratory occlusion manoeuvre and P0.1 with PMI obtained at various degrees of expiratory cycling threshold?
• does airway resistance - evaluated by using esophageal pressure - correlate with the estimation of airway resistance on the pressure-time waveform by a high percentage of expiratory cycling mimicking the interrupter technique?

Conditions

Respiratory Failure

Keywords

pressure support; esophageal pressure; pressure muscle index; expiratory cycling; inspiratory effort; plateau pressure; transpulmonary pressure; airway resistance; occlusion pressure

Outcome Measures

Primary Outcomes (1)

• Pressure muscle index (PMI) as a bedside estimation of inspiratory effort at different expiratory cycling levels during different levels of pressure support.

  To verify whether pressure muscle index (PMI) - obtained by the pressure time waveform on the ventilator and used as an estimation of the inspiratory effort - is differently correlated with esophageal pressure swing (i.e. gold standard to describe the inspiratory effort) by changing expiratory cycling, over different levels of pressure support ventilation.

  After at least 6 hours after and within 72 hours since switch from controlled ventilation to pressure support ventilation.

Secondary Outcomes (3)

• Correlation between PMI and other measures of inspiratory effort (Pocc) and inspiratory drive (P0.1).

  After at least 6 hours after and within 72 hours since switch from controlled ventilation to pressure support ventilation

• Airway resistances during assisted mechanical ventilation.

  After at least 6 hours after and within 72 hours since switch from controlled ventilation to pressure support ventilation

• Tidal volume variability

  After at least 6 hours after and within 72 hours since switch from controlled ventilation to pressure support ventilation

Study Arms (4)

Prolonged expiratory cycling

EXPERIMENTAL

15% expiratory cycling during pressure support ventilation

Other: Expiratory cycling change at different levels of pressure support ventilation

Late expiratory cycling

EXPERIMENTAL

30% expiratory cycling during pressure support ventilation

Other: Expiratory cycling change at different levels of pressure support ventilation

Medium expiratory cycling

EXPERIMENTAL

45% expiratory cycling during pressure support ventilation

Other: Expiratory cycling change at different levels of pressure support ventilation

Early expiratory cycling

EXPERIMENTAL

60% expiratory cycling during pressure support ventilation

Other: Expiratory cycling change at different levels of pressure support ventilation

Interventions

Expiratory cycling change at different levels of pressure support ventilation OTHER

Four different levels of expiratory cycling will be randomly applied at 3 different degrees of pressure support. Three end-inspiratory and three end-expiratory occlusion manoeuvres will be carried out at the end of 10 minute steps of ventilation during each set value expiratory cycling and pressure support level. Total study time will be about 120 minutes. Levels of pressure support wil be clinical pressure support ± 4 cmH2O; expiratory cycling percentages applied for each pressure support step will be 15%, 30%, 45% and 60% of peak inspiratory flow.

Early expiratory cycling; Late expiratory cycling; Medium expiratory cycling; Prolonged expiratory cycling

Eligibility Criteria

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

You may qualify if:

• Invasive mechanical ventilation in PSV
• Presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 72 hours after
• Weaning from mechanical ventilation
• Patient for full active management
• Subject ≥ 18 years
• Informed consent

You may not qualify if:

• Age \<18 years old
• Pregnancy
• Active air leaks
• Chronic Obstructive Pulmonary Disease and/or asthma
• Moribund state
• Neurological conditions potentially impairing the ventilatory drive (e.g. meningitis, encephalitis) and neuromuscular diseases impairing neuromuscular conduction (e.g. Guillain-Barre syndrome)
• Extracorporeal membrane oxygenation (ECMO)

Sponsors & Collaborators

• Fondazione IRCCS San Gerardo dei Tintori: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

Location

Related Publications (6)

• Foti G, Cereda M, Banfi G, Pelosi P, Fumagalli R, Pesenti A. End-inspiratory airway occlusion: a method to assess the pressure developed by inspiratory muscles in patients with acute lung injury undergoing pressure support. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1210-6. doi: 10.1164/ajrccm.156.4.96-02031.

  PMID: 9351624 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

• Teggia-Droghi M, Grassi A, Rezoagli E, Pozzi M, Foti G, Patroniti N, Bellani G. Comparison of Two Approaches to Estimate Driving Pressure during Assisted Ventilation. Am J Respir Crit Care Med. 2020 Dec 1;202(11):1595-1598. doi: 10.1164/rccm.202004-1281LE. No abstract available.

  PMID: 32678669 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

• Bianchi I, Grassi A, Pham T, Telias I, Teggia Droghi M, Vieira F, Jonkman A, Brochard L, Bellani G. Reliability of plateau pressure during patient-triggered assisted ventilation. Analysis of a multicentre database. J Crit Care. 2022 Apr;68:96-103. doi: 10.1016/j.jcrc.2021.12.002. Epub 2021 Dec 21.

  PMID: 34952477 BACKGROUND

• Pesenti A, Pelosi P, Foti G, D'Andrea L, Rossi N. An interrupter technique for measuring respiratory mechanics and the pressure generated by respiratory muscles during partial ventilatory support. Chest. 1992 Sep;102(3):918-23. doi: 10.1378/chest.102.3.918.

  PMID: 1516422 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Emanuele Rezoagli, MD, PhD

  University of Milano-Bicocca, Monza, Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Crossover randomisation of different levels of expiratory cycling during randomised levels of pressure support ventilation in critically ill patients undergoing assisted mechanical ventilation.

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)