NCT03607240

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

July 1, 2018

Last Update Submit

October 16, 2019

Conditions

Pulmonary Atelectasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • modified lung ultrasound score at post-anesthesia care unit (PACU)

    intraoperative

  • incidence of atelectasis diagnosed by ultrasonography

    intraoperative

  • arterial blood gas analyses

    intraoperative

  • incidence of postoperative complications

    during the postoperative period until discharge from hospital, an average of 3 days

  • intraoperative mean arterial pressure

    intraoperative

  • +3 more secondary outcomes

Study Arms (2)

LUS-guided alveolar recruitment

EXPERIMENTAL

Lung ultrasound-guided alveolar recruitment maneuver will be performed

Procedure: lung ultrasound-guided alveolar recruitment

conventional alveolar recruitment

ACTIVE COMPARATOR

Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds.

Procedure: conventional alveolar recruitment

Interventions

lung ultrasound-guided alveolar recruitmentPROCEDURE

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.

LUS-guided alveolar recruitment
conventional alveolar recruitmentPROCEDURE

Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds

conventional alveolar recruitment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jin-Tae Kim

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 27669555BACKGROUND

  • 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.

    PMID: 27804117BACKGROUND

  • 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.

    PMID: 33399385DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jin-Tae Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2018

First Posted

July 31, 2018

Study Start

August 6, 2018

Primary Completion

January 10, 2019

Study Completion

January 15, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)