Recruiting NCT07362680
Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing Total Laparoscopic Hysterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the sustained inflation recruitment maneuver, the incremental PEEP recruitment maneuver, the Ultrasound-guided recruitment maneuver.
- Who it may be relevant to
- Registry conditions: Total Laparoscopic Hysterectomy, Atelectasis, Postoperative. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure the sustained inflation recruitment maneuver
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. - Procedure the incremental PEEP recruitment maneuver
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. - Procedure the Ultrasound-guided recruitment maneuver
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 i
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Recruitment volume measured by the ΔEELV method [Time frame: Perioperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital of Xinxiang Medical College — Xinxiang
Identifiers
NCT: NCT07362680 · EC-25-117