Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

Not Applicable

Completed

• Conditions: Pulmonary Atelectasis
• Interventions: Procedure: lung ultrasound-guided alveolar recruitment; Procedure: conventional alveolar recruitment

• Registration Number: NCT03607240
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The study aims to compare the degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2018-08-06
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Adult patients scheduled to undergo elective laparoscopic gynecological surgery (laparoscopic ovarian cystectomy or laparoscopic salpingo-oophorectomy or laparoscopic hysterectomy or laparoscopic myomectomy) under general anesthesia, with ASA physical status classification I or II

Exclusion Criteria

• Previous history of lung surgery
• Patients having pneumonia, pneumothorax, or pleural effusion in preoperative chest X-ray
• Patients with COPD, emphysema
• Patients with previous history of pneumothorax, or bullae
• Morbid cardiac disease
• Adolescent aged < 18 years
• Anticipated duration of surgery < 1 hour

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUS-guided alveolar recruitment	lung ultrasound-guided alveolar recruitment	Lung ultrasound-guided alveolar recruitment maneuver will be performed
conventional alveolar recruitment	conventional alveolar recruitment	Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds.

Primary Outcome Measures

Name	Time	Method
modified lung ultrasound score at the end of surgery	At the end of surgery	Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).

Secondary Outcome Measures

Name	Time	Method
intraoperative SpO2	intraoperative	SpO2 in %
modified lung ultrasound score at post-anesthesia care unit (PACU)	intraoperative	Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).
incidence of atelectasis diagnosed by ultrasonography	intraoperative	the presence of atelectasis by ultrasonography
arterial blood gas analyses	intraoperative	PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)
incidence of postoperative complications	during the postoperative period until discharge from hospital, an average of 3 days	fever, pneumonia, atelectasis diagnosed by chest X-ray
intraoperative mean arterial pressure	intraoperative	mean arterial pressure in mmHg
intraoperative peak airway pressure	intraoperative	peak airway pressure in cmH2O
Incidence of postoperative shoulder pain at POD #1	assessed at postoperative day 1	patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of