THE EFFECT OF ALVEOLAR RECRUITMENT MANOEUVRE ON INTRAOPERATIVE HAEMODYNAMICS

December 9, 2025 updated by: Ozlem Sagir, MD, Balikesir University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

During laparoscopic hysterectomy, pneumoperitoneum is created with carbon dioxide (CO₂) to provide surgical field of view and the patient is placed in Trendelenburg position. This increases intrathoracic pressure, decreases lung compliance and increases the risk of atelectasis. Therefore, lung protective ventilation strategies such as alveolar recruitment manoeuvre (RM), individualised PEEP application and low tidal volume are recommended. RM aims to increase lung compliance and prevent atelectasis by reopening collapsed alveoli. However, changes in haemodynamic parameters, especially mean arterial pressure and cardiac output, may occur during RM. In addition to standard monitoring for the management of these changes, haemodynamic evaluation can be performed with minimally invasive methods such as arterial waveform analysis. In this study, we aimed to evaluate the effects of RM applied during laparoscopic hysterectomy on intraoperative haemodynamic parameters using arterial waveform analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Alveolar Recruitment Maneuver Applied
Alveolar Recruitment Maneuver Not Applied

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of RM on heart rate (in bpm)
Time Frame: perioperatively
measurement of heart rate in bpm
perioperatively
Effect of RM on pressure mmHg
Time Frame: perioperatively
blood pressure measurement in mmmercury
perioperatively
Effect of RM on Cardiac index(CI)
Time Frame: intraoperatively
Cardiac Index measurement via an arterial cannula as l/min/m2
intraoperatively
Effect of RM on stroke volume index(SVI)
Time Frame: intraoperatively
SVI measurement via arterial cannula as L/min/m2
intraoperatively
Effect of RM on pulse pressure variablity(PPV)
Time Frame: intraoperatively
pulse pressure variability measured by finger probe as cm/s
intraoperatively
Effect of RM on systemic vascular resistance index(SVRI)
Time Frame: intraoperatively
systemic vascular resistance index(SVRI) measurement via arterial cannula as L/min/m2
intraoperatively
Effect of RM on cardiac power index(CPI)
Time Frame: intraoperatively
cardiac power index(CPI) measurement via arterial line as ml/min/m2
intraoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of RM on Compliance
Time Frame: intraoperatively
measurement of dynamic compliance by Ventilator as Cdyn
intraoperatively
Effect of RM on Oxygenation
Time Frame: İntraoperatively
measurement of oxygenation via obtaining partial blood oxygene pressure via arterial blood sample pulse oxymeter as %
İntraoperatively
Postoperative pulmonary comlications (infection, bronchospasm, pleural effusion, atelectasis, respiratory failure)
Time Frame: postoperative day 1 and 3
assessment of pulmonary complications
postoperative day 1 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balikesir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ahmet Koroglu, Professor, medical doctor, Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BalikesirU OSagır 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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