- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299396
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
Completed
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
Observational
Enrollment (Actual)
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
-
-
-
Balıkesir, Turkey (Türkiye), 10145
- Balikesir University
-
-
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
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 |
|---|
|
Alveolar Recruitment Maneuver Applied
|
|
Alveolar Recruitment Maneuver Not Applied
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
January 9, 2023
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
April 9, 2025
First Submitted That Met QC Criteria
December 9, 2025
First Posted (Actual)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 9, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID 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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