Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery
Primary Purpose
Pulmonary Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lung ultrasound-guided alveolar recruitment
conventional alveolar recruitment
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Atelectasis
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
Sites / Locations
- Jin-Tae Kim
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LUS-guided alveolar recruitment
conventional alveolar recruitment
Arm Description
Lung ultrasound-guided alveolar recruitment maneuver will be performed
Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
incidence of atelectasis diagnosed by ultrasonography
the presence of atelectasis by ultrasonography
arterial blood gas analyses
PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)
incidence of postoperative complications
fever, pneumonia, atelectasis diagnosed by chest X-ray
intraoperative mean arterial pressure
mean arterial pressure in mmHg
intraoperative SpO2
SpO2 in %
intraoperative peak airway pressure
peak airway pressure in cmH2O
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
Full Information
NCT ID
NCT03607240
First Posted
July 1, 2018
Last Updated
October 16, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03607240
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LUS-guided alveolar recruitment
Arm Type
Experimental
Arm Description
Lung ultrasound-guided alveolar recruitment maneuver will be performed
Arm Title
conventional alveolar recruitment
Arm Type
Active Comparator
Arm Description
Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds.
Intervention Type
Procedure
Intervention Name(s)
lung ultrasound-guided alveolar recruitment
Intervention Description
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
Intervention Name(s)
conventional alveolar recruitment
Intervention Description
Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds
Primary Outcome Measure Information:
Title
modified lung ultrasound score at the end of surgery
Description
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).
Time Frame
At the end of surgery
Secondary Outcome Measure Information:
Title
modified lung ultrasound score at post-anesthesia care unit (PACU)
Description
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).
Time Frame
intraoperative
Title
incidence of atelectasis diagnosed by ultrasonography
Description
the presence of atelectasis by ultrasonography
Time Frame
intraoperative
Title
arterial blood gas analyses
Description
PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)
Time Frame
intraoperative
Title
incidence of postoperative complications
Description
fever, pneumonia, atelectasis diagnosed by chest X-ray
Time Frame
during the postoperative period until discharge from hospital, an average of 3 days
Title
intraoperative mean arterial pressure
Description
mean arterial pressure in mmHg
Time Frame
intraoperative
Title
intraoperative SpO2
Description
SpO2 in %
Time Frame
intraoperative
Title
intraoperative peak airway pressure
Description
peak airway pressure in cmH2O
Time Frame
intraoperative
Title
Incidence of postoperative shoulder pain at POD #1
Description
patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale
Time Frame
assessed at postoperative day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27669555
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.
Results Reference
background
PubMed Identifier
27804117
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.
Results Reference
background
PubMed Identifier
33399385
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.
Results Reference
derived
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Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery
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