NCT06625099

Brief Summary

The aim of this study is to compare the effects of standard and optimum positive end expiratory pressures on mechanical power during laparoscopic surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

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 12, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

October 1, 2024

Last Update Submit

November 19, 2025

Conditions

Keywords

Mechanical PowerOptimum PEEPLaparoscopic abdominal surgerymechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Mechanical power value in optimum PEEP

    The primary aim of this study is to calculate the mechanical power values (in Joule/min) applied during ventilation among the optimum positive expiratory pressure values in patients undergoing laparoscopic surgery are higher than in patients applied low PEEP.

    During the intraoperative period laparoscopic surgery

Secondary Outcomes (1)

  • Effect of high mechanical power on oxygenation in blood gases

    During the intraoperative period laparoscopic surgery

Study Arms (2)

Group L

After the study group patients were informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the randomly grouped patients after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to the groups they are in. Group L patients will be applied standard 5 cmH2O PEEP after anesthesia induction. The ventilation parameters and vital signs obtained will be recorded, and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume controlled patients. The groups will be compared for power hemodynamic values and blood gas for oxygenation.

Other: Mechanical Ventilation (MV) with Low PEEP

Group O

After the study group patients are informed preoperatively and accepted to participate in the study, different mechanical ventilation strategies will be applied to the patients randomly grouped after standard propofol, fentanyl, rocuronium midazolam induction anesthesia according to their groups. Optimum PEEP will be applied to Group O patients after anesthesia induction, with the highest compliance values. The ventilation parameters and vital signs obtained will be recorded and the mechanical power applied to the patients will be calculated according to Gattinoni's mechanical power calculation formula in volume-controlled patients. The groups will be compared in terms of power hemodynamic values and blood gas for oxygenation.

Other: Mechanical Ventilation (MV) with Optimum PEEP

Interventions

Mechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and 5cmH2o PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded.

Group L

Mechanical Ventilation (MV) with Low PEEP During volume controlled ventilation, blood gas values and mechanical power calculations of patients ventilated at 6-8ml/kg tidal volume and optimum PEEP, I/E: 1/2, 10-14 frequency ranges will be recorded. The optimum PEEP will be adjusted by titrating to the highest compliance with the open lung strategy.

Group O

Eligibility Criteria

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

Patients scheduled to undergo laparoscopic cholecystectomy in the operating rooms of Kocaeli City Hospital will constitute the study universe.

You may qualify if:

  • within the appropriate age range
  • agreeing to participate in the study
  • again receiving lancetesthesia
  • volume controlled ventilation
  • no known lung disease
  • no known coronary artery disease
  • ASA class 1-2 patients

You may not qualify if:

  • Patients who do not want to be included in the study will not be included
  • Patients with intraoperative deep hypotension (mean arterial pressure \<50) will be excluded.
  • Those who develop intraoperative hypothermia or have other anesthesia complications will be excluded.
  • Patients who will not be extubated postoperatively will be excluded from the study.
  • Those with neurological diseases or those using psychiatric medications will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

Location

Related Publications (7)

  • Jo YY, Chang YJ, Lee D, Kim YB, Jung J, Kwak HJ. Comparisons of Mechanical Power and Respiratory Mechanics in Pressure-Controlled Ventilation and Volume-Controlled Ventilation during Laparoscopic Cholecystectomy in Elderly Patients. J Pers Med. 2023 Jan 23;13(2):201. doi: 10.3390/jpm13020201.

    PMID: 36836435BACKGROUND
  • Pozzi T, Coppola S, Catozzi G, Colombo A, Chioccola M, Duscio E, Di Marco F, Chiumello D. Mechanical power during robotic-assisted laparoscopic prostatectomy: an observational study. J Clin Monit Comput. 2024 Oct;38(5):1135-1143. doi: 10.1007/s10877-024-01170-1. Epub 2024 Jun 17.

    PMID: 38884875BACKGROUND
  • Romitti F, Busana M, Palumbo MM, Bonifazi M, Giosa L, Vassalli F, Gatta A, Collino F, Steinberg I, Gattarello S, Lazzari S, Palermo P, Nasr A, Gersmann AK, Richter A, Herrmann P, Moerer O, Saager L, Camporota L, Marini JJ, Quintel M, Meissner K, Gattinoni L. Mechanical power thresholds during mechanical ventilation: An experimental study. Physiol Rep. 2022 Mar;10(6):e15225. doi: 10.14814/phy2.15225.

    PMID: 35340133BACKGROUND
  • 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
  • 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
  • Silva PL, Ball L, Rocco PRM, Pelosi P. Physiological and Pathophysiological Consequences of Mechanical Ventilation. Semin Respir Crit Care Med. 2022 Jun;43(3):321-334. doi: 10.1055/s-0042-1744447. Epub 2022 Apr 19.

    PMID: 35439832BACKGROUND
  • Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.

    PMID: 34597688BACKGROUND

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Ahmet Yuksek, Md

    Kocaeli City Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Anesthesiology

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

September 12, 2024

Primary Completion

October 5, 2025

Study Completion

October 5, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The data of the study patients belong to Kocaeli City Hospital and it is forbidden to share them.

Locations