NCT07362680

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
May 2025Aug 2026

Study Start

First participant enrolled

May 2, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

December 18, 2025

Last Update Submit

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 COMPARATOR

the sustained inflation recruitment maneuver group, n=30

Procedure: the sustained inflation recruitment maneuver

the PRM group

ACTIVE COMPARATOR

the incremental PEEP recruitment maneuver group, n=30

Procedure: the incremental PEEP recruitment maneuver

the URM group

EXPERIMENTAL

the Ultrasound-guided recruitment maneuver group, n=30

Procedure: the Ultrasound-guided recruitment maneuver

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.

the SRM group

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.

the PRM group

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.

the URM group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

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

Locations