Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing Total Laparoscopic Hysterectomy
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2025
CompletedFirst Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
January 23, 2026
January 1, 2026
1.3 years
December 18, 2025
January 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Perioperative
Secondary Outcomes (1)
Recruitment volume measured by the ΔEELV method
Perioperative
Study Arms (3)
the SRM group
ACTIVE COMPARATORthe sustained inflation recruitment maneuver group, n=30
the PRM group
ACTIVE COMPARATORthe incremental PEEP recruitment maneuver group, n=30
the URM group
EXPERIMENTALthe Ultrasound-guided recruitment maneuver group, n=30
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 23, 2026
Study Start
May 2, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01