NCT06274372

Brief Summary

It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations.

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 not_applicable

Timeline
Completed

Started Aug 2023

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

First Submitted

Initial submission to the registry

January 24, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

January 24, 2023

Last Update Submit

September 22, 2024

Conditions

Laparoscopic Surgeries

Keywords

flow controlled ventilationlaparoscopy

Outcome Measures

Primary Outcomes (5)

  • effects of flow controlled ventilation on arterial pressure

    Arterial blood pressure in mmHg

    intraoperatively

  • effectcs of flow controlled ventiletion on endtidal CO2

    endtidal CO2 in mmHg

    intraoperatively

  • effects of flow controlled ventilation on mean arterial pressure

    mean arterial pressure change in percent

    intraoperatively

  • effects of flow controlled ventilation on heart rate

    heart rate in bpm

    intraoperatively

  • effectcs of flow controlled ventiletion on peak airway pressure

    peak airway pressure in cmH2O

    intraoperatively

Secondary Outcomes (1)

  • respiratory related complications

    intraoperative period and postoperative first week

Study Arms (2)

control group

OTHER

patients ventilated with volume controlled ventilation

Device: volume controlled ventilation

flow controlled ventilation

EXPERIMENTAL

patients ventilated with flow controlled ventilation

Device: flow controlled ventilation

Interventions

flow controlled ventilationDEVICE

effects of flow controlled ventilation

flow controlled ventilation
volume controlled ventilationDEVICE

effects of volume controlled ventilation

control group

Eligibility Criteria

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

You may not qualify if:

  • patients who do not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Training and Research Hospital

Derince, Kocaeli, 41900, Turkey (Türkiye)

Location

Study Officials

  • Nurseda Dundar, MD

    Kocaeli City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 23, 2024

Study Start

August 7, 2023

Primary Completion

August 6, 2024

Study Completion

August 6, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)