Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Atelectasis
• Intervention / Treatment: Procedure: lung ultrasound-guided alveolar recruitment; Procedure: conventional alveolar recruitment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LUS-guided alveolar recruitment; Lung ultrasound-guided alveolar recruitment maneuver will be performed	Procedure: lung ultrasound-guided alveolar recruitment; Alveolar recruitment maneuver will be performed under lung ultrasound-guidance. Positive pressure will be not exceed 40cmH2O and duration of positive pressure inflation will not exceed 10 seconds.
ACTIVE_COMPARATOR: conventional alveolar recruitment; Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds.	Procedure: conventional alveolar recruitment; Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified lung ultrasound score 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).	At the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified lung ultrasound score at post-anesthesia care unit (PACU)	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).	intraoperative
incidence of atelectasis diagnosed by ultrasonography	the presence of atelectasis by ultrasonography	intraoperative
arterial blood gas analyses	PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)	intraoperative
incidence of postoperative complications	fever, pneumonia, atelectasis diagnosed by chest X-ray	during the postoperative period until discharge from hospital, an average of 3 days
intraoperative mean arterial pressure	mean arterial pressure in mmHg	intraoperative
intraoperative SpO2	SpO2 in %	intraoperative
intraoperative peak airway pressure	peak airway pressure in cmH2O	intraoperative
Incidence of postoperative shoulder pain at POD #1	patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale	assessed at postoperative day 1

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2018
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): January 15, 2019

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: H-1805-148-948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No