NCT06413472

Brief Summary

We aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

May 9, 2024

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • MPgeo

    The mechanical power (MPgeo) values measured using the geometric method .

    40 minute

  • Energy

    Energy values measured using the geometric method .

    40 minute

Study Arms (2)

ARDS patients-PCV

Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV).

Procedure: Mechanical ventilator adjustment for PCV

ARDS patients-VCV

Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV).

Procedure: Mechanical ventilator adjustment for VCV

Interventions

In pressure control ventilation (PCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive.

ARDS patients-PCV

In volume control ventilation (VCV) mode, patients will be ventilated for 5 minutes at a Tslope of 5% and another 5 minutes at 15% for both 1:1 and 1:2 I:E ratios. After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained . A total of 20 P-V loop screenshots will be captured over a 20-minute period (10 for the 1:2 ratio and 10 for the 1:1 ratio), which will be stored in the ventilators memory. The stored data will then be transferred from the ventilators memory to a computer via a flash drive.

ARDS patients-VCV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

"Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital."

You may qualify if:

  • ARDS (Acute Respiratory Distress Syndrome) patients.
  • Patients who are deeply sedated.
  • Patients ventilated in:
  • Pressure-Controlled Ventilation (PCV or PRVC) mode, or
  • Volume-Controlled Ventilation (VCV) mode.
  • Patients within the 24-48 hour period of their stay in the intensive care unit.

You may not qualify if:

  • Patients with incomplete data.
  • Patients diagnosed with:
  • COPD (Chronic Obstructive Pulmonary Disease),
  • Heart failure.
  • Pregnant patients.
  • Patients with a thoracopleural fistula.
  • Hemodynamically unstable patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

  • Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.

    PMID: 35644896BACKGROUND
  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

    PMID: 27620287BACKGROUND
  • Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.

    PMID: 30291378BACKGROUND
  • Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.

    PMID: 31931417BACKGROUND
  • Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.

    PMID: 31773328BACKGROUND
  • Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11.

    PMID: 32780353BACKGROUND
  • Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.

    PMID: 31101961BACKGROUND
  • van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.

    PMID: 31359082BACKGROUND
  • Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4.

    PMID: 35224956BACKGROUND
  • Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6.

    PMID: 38117345BACKGROUND
  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

    PMID: 22797452BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

March 1, 2024

Primary Completion

May 31, 2024

Study Completion

June 1, 2024

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations