- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362680
Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing Total Laparoscopic Hysterectomy
January 15, 2026 updated by: The First Affiliated Hospital of Xinxiang Medical College
This study aims to evaluate the lung-protective effects of ultrasound-guided lung recruitment maneuvers in patients with OSA undergoing total laparoscopic hysterectomy and to explore the efficacy of EELV measurement in assessing the effectiveness of these maneuvers.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
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
-
-
Henan
-
Xinxiang, Henan, China, 453100
- Recruiting
- The First Affiliated Hospital of Xinxiang Medical College
-
Contact:
- Kaiyuan Zheng
- Phone Number: +86 13938459823
- Email: zhengkaiyuan0624@163.cm
-
-
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
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Scheduled for elective total laparoscopic hysterectomy;
- American Society of Anesthesiologists (ASA) I to III;
- BMI > 28 kg/m²;
- STOP-BANG score ≥ 3.
Exclusion Criteria:
- Abnormal findings on preoperative chest X-ray or CT, such as atelectasis, pneumothorax, thoracic deformity, pleural effusion, or neuromuscular diseases;
- Pre-existing severe pulmonary diseases;
- Severe cardiac arrhythmias or a history of cardiac surgery;
- Allergy to any medications used in the study.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: the SRM group
the sustained inflation recruitment maneuver group, n=30
|
The APL valve on the anaesthesia machine will be adjusted to 30 cmH₂O, and the rapid oxygen inflow valve will be pressed to increase the pressure to the maximum, maintaining the pressure for 30 seconds.
|
|
Active Comparator: the PRM group
the incremental PEEP recruitment maneuver group, n=30
|
Starting from 5 cmH₂O, PEEP will be titrated upwards in 5 cmH₂O increments every 30 seconds until a maximum of 30 cmH₂O is reached.
After maintaining for 40 seconds, PEEP will be decreased by 5 cmH₂O every 30 seconds until it returns to the pre-recruitment level.
|
|
Experimental: the URM group
the Ultrasound-guided recruitment maneuver group, n=30
|
Lung ultrasound will be performed on patients.
If any lung region has an LUS score ≥ 2, ultrasound-guided RM will be performed; otherwise, no operation will be conducted.
After the ultrasound examination, the probe will be positioned over the lung region exhibiting the most severe aeration loss (highest LUS) to guide the RMs.
The ventilator will be set to pressure-controlled ventilation (PCV), maintaining the inspiratory pressure at 40 cmH₂O.
PEEP will be gradually increased from 5 cmH₂O, with increments of 5 cmH₂O every 5-10 seconds, until ultrasound shows no atelectatic areas.
The pressure will be maintained at 40 cmH₂O for 40 seconds.
An airway pressure ceiling of 40 cmH₂O was established, and the pressure and the time used for the RM will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The lung ultrasound scores of patients after endotracheal intubation (T1), after the first lung recruitment procedure (T2), after the operation (T3), after the second lung recruitment procedure (T4), and 30 minutes after extubation (T5)
Time Frame: Perioperative
|
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recruitment volume measured by the ΔEELV method
Time Frame: Perioperative
|
Perioperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 2, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
December 18, 2025
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC-25-117
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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