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
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