Clinical trial NCT03607240: Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery
Official title: The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: modified lung ultrasound score at the end of surgery
timeFrame: At the end of surgery
Secondary outcomes:
measure: modified lung ultrasound score at post-anesthesia care unit (PACU)
timeFrame: intraoperative
measure: incidence of atelectasis diagnosed by ultrasonography
timeFrame: intraoperative
measure: arterial blood gas analyses
timeFrame: intraoperative
measure: incidence of postoperative complications
timeFrame: during the postoperative period until discharge from hospital, an average of 3 days
measure: intraoperative mean arterial pressure
timeFrame: intraoperative
measure: intraoperative SpO2
timeFrame: intraoperative
measure: intraoperative peak airway pressure
timeFrame: intraoperative
measure: Incidence of postoperative shoulder pain at POD #1
timeFrame: assessed at postoperative day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
citation: Song IK, Kim EH, Lee JH, Ro S, Kim HS, Kim JT. Effects of an alveolar recruitment manoeuvre guided by lung ultrasound on anaesthesia-induced atelectasis in infants: a randomised, controlled trial. Anaesthesia. 2017 Feb;72(2):214-222. doi: 10.1111/anae.13713. Epub 2016 Nov 2.
citation: Park SK, Yang H, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-guided versus conventional lung recruitment manoeuvres in laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(3):275-284. doi: 10.1097/EJA.0000000000001435.