NCT07299396

Brief Summary

Alveolar recruitment manoeuvre plays a key role in the prevention of atelectasis. In addition, it affects haemodynamic parameters. This study aims to investigate the effects of RM on haemodynamic parameters using minimally invasive monitoring techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

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

January 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

lung protective ventilationrecruitment manoeuvrelaparoscopic surgeryhaemodynamic changes

Outcome Measures

Primary Outcomes (7)

  • Effect of RM on heart rate (in bpm)

    measurement of heart rate in bpm

    perioperatively

  • Effect of RM on pressure mmHg

    blood pressure measurement in mmmercury

    perioperatively

  • Effect of RM on Cardiac index(CI)

    Cardiac Index measurement via an arterial cannula as l/min/m2

    intraoperatively

  • Effect of RM on stroke volume index(SVI)

    SVI measurement via arterial cannula as L/min/m2

    intraoperatively

  • Effect of RM on pulse pressure variablity(PPV)

    pulse pressure variability measured by finger probe as cm/s

    intraoperatively

  • Effect of RM on systemic vascular resistance index(SVRI)

    systemic vascular resistance index(SVRI) measurement via arterial cannula as L/min/m2

    intraoperatively

  • Effect of RM on cardiac power index(CPI)

    cardiac power index(CPI) measurement via arterial line as ml/min/m2

    intraoperatively

Secondary Outcomes (3)

  • Effect of RM on Compliance

    intraoperatively

  • Effect of RM on Oxygenation

    İntraoperatively

  • Postoperative pulmonary comlications (infection, bronchospasm, pleural effusion, atelectasis, respiratory failure)

    postoperative day 1 and 3

Study Arms (2)

Alveolar Recruitment Maneuver Applied

Alveolar Recruitment Maneuver Not Applied

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailslaparoscopic hysterectomy patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* ASA I-II risk group patients * Patients between 18-70 y undergoing laparoscopic hysterectomy surgery

You may qualify if:

  • ASA Class 1-2 patients 18-70 years old

You may not qualify if:

  • \<18 y, BMI\>40
  • Patients receiving invasive mechanical ventilator support in the last 1 month
  • Patients who have received chemotherapy or radiotherapy in the last 2 months
  • Those with severe lung disease (COPD, asthma, pulmonary infection, bronchiectasis, previous need for non-invasive mechanical ventilation, oxygen therapy or steroid therapy for acute attack)
  • Known severe pulmonary hypertension
  • Patient refusal to participate in the study
  • Intracranial tumour
  • Haemodynamic instability
  • Shock
  • Neuromuscular disease
  • Pathologies causing increased intracranial and intraocular pressure
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

Study Officials

  • Ahmet Koroglu, Professor, medical doctor

    Balikesir University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

April 9, 2025

First Posted

December 23, 2025

Study Start

January 9, 2023

Primary Completion

August 1, 2023

Study Completion

August 15, 2023

Last Updated

December 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations