NCT05690867

Brief Summary

Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

September 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

October 18, 2022

Last Update Submit

January 18, 2023

Conditions

Keywords

mechanical powervolume controlled ventilationpressure controlled ventilation

Outcome Measures

Primary Outcomes (1)

  • calculation of mechanical power changes in two different ventilation modes

    mechanical power will be calculated using the Van der Meijden's formula for pressure support ventilation and Gattinoni's formula for volume controlled ventilation and two mechanical powers will be compared

    change from at the beginning of surgery till the end of surgery

Secondary Outcomes (2)

  • postoperative pulmonary complications

    post-operative 7 days

  • hospitalisation time

    up to 20 days

Study Arms (2)

Group 1

OTHER

group 1 starts with volume controlled ventilation

Other: Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes

Group 2

OTHER

group 2 starts with pressure controlled ventilation

Other: Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes

Interventions

group 1 starts with volume controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to pressure controlled ventilation after letting washout we take three consecutive measurements at pressure controlled ventilation and we will repeat this protocol during surgery

Group 1

group 2 starts with pressure controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to volume controlled ventilation after letting washout we take three consecutive measurements at volume controlled ventilation and we will repeat this protocol during surgery

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA1-2 , \>18 years old patients having upper abdominal surgery

You may not qualify if:

  • chronic obstructive lung disease, interstitial lung disease
  • chronic renal failure
  • Child-Pugh \> 6 liver disease
  • Patients who don't give consent
  • NYHA \> 2 heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.

    PMID: 28701178BACKGROUND
  • 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

Study Officials

  • Istanbul University

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2022

First Posted

January 19, 2023

Study Start

September 5, 2022

Primary Completion

November 5, 2022

Study Completion

December 5, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations