Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

NCT ID: NCT03607240

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2019-01-15

Brief Summary

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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

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Conditions

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Pulmonary Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LUS-guided alveolar recruitment

Lung ultrasound-guided alveolar recruitment maneuver will be performed

Group Type EXPERIMENTAL

lung ultrasound-guided alveolar recruitment

Intervention Type PROCEDURE

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.

conventional alveolar recruitment

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

Group Type ACTIVE_COMPARATOR

conventional alveolar recruitment

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

conventional alveolar recruitment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Jin-Tae Kim

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 27669555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27804117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33399385 (View on PubMed)

Other Identifiers

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H-1805-148-948

Identifier Type: -

Identifier Source: org_study_id

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