ASA Class I/II Patients Scheduled for Surgery Under General AnesthesiaNCT07299396
THE EFFECT OF ALVEOLAR RECRUITMENT MANOEUVRE ON INTRAOPERATIVE HAEMODYNAMICS
An observational study of ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia and Laparoscopic Hysterectomy, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia, Laparoscopic Hysterectomy
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2023to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * ASA I-II risk group patients * Patients between 18-70 y undergoing laparoscopic hysterectomy surgery
Who may be able to join
- ASA Class 1-2 patients 18-70 years old
Who cannot join
- <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
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- Intracranial tumour
- Haemodynamic instability
- Shock
- Neuromuscular disease
- Pathologies causing increased intracranial and intraocular pressure
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia, Laparoscopic Hysterectomy
- Keywords
- lung protective ventilation, recruitment manoeuvre, laparoscopic surgery, haemodynamic changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar Recruitment Maneuver Applied | Not described | |
| Alveolar Recruitment Maneuver Not Applied | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RM on heart rate (in bpm)
measurement of heart rate in bpm
Measured: perioperatively
Effect of RM on pressure mmHg
blood pressure measurement in mmmercury
Measured: perioperatively
Effect of RM on Cardiac index(CI)
Cardiac Index measurement via an arterial cannula as l/min/m2
Measured: intraoperatively
Effect of RM on stroke volume index(SVI)
SVI measurement via arterial cannula as L/min/m2
Measured: intraoperatively
Effect of RM on pulse pressure variablity(PPV)
pulse pressure variability measured by finger probe as cm/s
Measured: intraoperatively
Effect of RM on systemic vascular resistance index(SVRI)
systemic vascular resistance index(SVRI) measurement via arterial cannula as L/min/m2
Measured: intraoperatively
Effect of RM on cardiac power index(CPI)
cardiac power index(CPI) measurement via arterial line as ml/min/m2
Measured: intraoperatively
Secondary outcomes (3)
Effect of RM on Compliance
measurement of dynamic compliance by Ventilator as Cdyn
Measured: intraoperatively
Effect of RM on Oxygenation
measurement of oxygenation via obtaining partial blood oxygene pressure via arterial blood sample pulse oxymeter as %
Measured: İntraoperatively
Postoperative pulmonary comlications (infection, bronchospasm, pleural effusion, atelectasis, respiratory failure)
assessment of pulmonary complications
Measured: postoperative day 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start9 Jan 2023
- Primary completion1 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA Class I/II Patients Scheduled for Surgery Under General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sagir, MD, Balikesir University
- Investigators
- Ahmet Koroglu, Professor, medical doctor, Study chair, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299396
- Sponsor's protocol ID
- BalikesirU OSagır 001
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ALVEOLAR RECRUITMENT MANOEUVRE ON INTRAOPERATIVE HAEMODYNAMICS
- ClinicalTrials.gov ID
- NCT07299396
- Acronym / sponsor ID
- BalikesirU OSagır 001
- Conditions
- ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia, Laparoscopic Hysterectomy
- Keywords
- lung protective ventilation, recruitment manoeuvre, laparoscopic surgery, haemodynamic changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar Recruitment Maneuver Applied | – | – |
| Alveolar Recruitment Maneuver Not Applied | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * ASA I-II risk group patients * Patients between 18-70 y undergoing laparoscopic hysterectomy surgery
Key inclusion criteria (1 listed)
- ASA Class 1-2 patients 18-70 years old
Key exclusion criteria (12 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of RM on heart rate (in bpm)
Time frame: perioperatively
measurement of heart rate in bpm
Effect of RM on pressure mmHg
Time frame: perioperatively
blood pressure measurement in mmmercury
Effect of RM on Cardiac index(CI)
Time frame: intraoperatively
Cardiac Index measurement via an arterial cannula as l/min/m2
Effect of RM on stroke volume index(SVI)
Time frame: intraoperatively
SVI measurement via arterial cannula as L/min/m2
Effect of RM on pulse pressure variablity(PPV)
Time frame: intraoperatively
pulse pressure variability measured by finger probe as cm/s
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
Effect of RM on cardiac power index(CPI)
Time frame: intraoperatively
cardiac power index(CPI) measurement via arterial line as ml/min/m2
3 secondary outcomes
Effect of RM on Compliance
Time frame: intraoperatively
Effect of RM on Oxygenation
Time frame: İntraoperatively
Postoperative pulmonary comlications (infection, bronchospasm, pleural effusion, atelectasis, respiratory failure)
Time frame: postoperative day 1 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Koroglu, Professor, medical doctor study chair
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia and Laparoscopic Hysterectomy, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of RM on heart rate (in bpm) (time frame: perioperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.