Total Laparoscopic HysterectomyNCT07362680
Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing Total Laparoscopic Hysterectomy
A study testing the sustained inflation recruitment maneuver, the incremental PEEP recruitment maneuver and the Ultrasound-guided recruitment maneuver in people with Total Laparoscopic Hysterectomy and Atelectasis, Postoperative, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy, Atelectasis, Postoperative
- What is being tested?
- the sustained inflation recruitment maneuver, the incremental PEEP recruitment maneuver and the Ultrasound-guided recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453100
Kaiyuan Zheng, +86 13938459823, zhengkaiyuan0624@163.cm
About this study
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.
- Being tested
- the sustained inflation recruitment maneuver, the incremental PEEP recruitment maneuver, the Ultrasound-guided recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the sustained inflation recruitment maneuverProcedure or surgery
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 incremental PEEP recruitment maneuverProcedure or surgery
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 Ultrasound-guided recruitment maneuverProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| the SRM group | Active comparator | the sustained inflation recruitment maneuver group, n=30 Receives: Procedure: the sustained inflation recruitment maneuver |
| the PRM group | Active comparator | the incremental PEEP recruitment maneuver group, n=30 Receives: Procedure: the incremental PEEP recruitment maneuver |
| the URM group | Experimental | the Ultrasound-guided recruitment maneuver group, n=30 Receives: Procedure: the Ultrasound-guided recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Perioperative
Secondary outcomes (1)
Recruitment volume measured by the ΔEELV method
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362680
- Sponsor's protocol ID
- EC-25-117
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07362680
- Acronym / sponsor ID
- EC-25-117
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the SRM group | Active comparator | Procedure: the sustained inflation recruitment maneuverthe sustained inflation recruitment maneuver group, n=30 |
| the PRM group | Active comparator | Procedure: the incremental PEEP recruitment maneuverthe incremental PEEP recruitment maneuver group, n=30 |
| the URM group | Experimental | Procedure: the Ultrasound-guided recruitment maneuverthe Ultrasound-guided recruitment maneuver group, n=30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the sustained inflation recruitment maneuverThe 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. | Procedure or surgery | the SRM group |
| the incremental PEEP recruitment maneuverStarting 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. | Procedure or surgery | the PRM group |
| the Ultrasound-guided recruitment maneuverLung 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. | Procedure or surgery | the URM group |
Primary outcome
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
1 secondary outcome
Recruitment volume measured by the ΔEELV method
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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.
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the sustained inflation recruitment maneuver, the incremental PEEP recruitment maneuver and the Ultrasound-guided recruitment maneuver in people with Total Laparoscopic Hysterectomy and Atelectasis, Postoperative, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Jan 2026.