Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03607240
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site: 20
• Patients Per Site Per Month: 3.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis	Procedure: lung ultrasound-guided alveolar recruitment; Procedure: conventional alveolar recruitment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery
• Actual Study Start Date: Aug 6, 2018
• Actual Primary Completion Date: Jan 10, 2019
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. modified lung ultrasound score at the end of surgery [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

1. modified lung ultrasound score at post-anesthesia care unit (PACU) [intraoperative]

   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).

2. incidence of atelectasis diagnosed by ultrasonography [intraoperative]

   the presence of atelectasis by ultrasonography

3. arterial blood gas analyses [intraoperative]

   PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)

4. incidence of postoperative complications [during the postoperative period until discharge from hospital, an average of 3 days]

   fever, pneumonia, atelectasis diagnosed by chest X-ray

5. intraoperative mean arterial pressure [intraoperative]

   mean arterial pressure in mmHg

6. intraoperative SpO2 [intraoperative]

   SpO2 in %

7. intraoperative peak airway pressure [intraoperative]

   peak airway pressure in cmH2O

8. Incidence of postoperative shoulder pain at POD #1 [assessed at postoperative day 1]

   patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jin-Tae Kim	Seoul		Korea, Republic of
2	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03607240
• Other Study ID Numbers: H-1805-148-948
• First Posted: Jul 31, 2018
• Last Update Posted: Oct 18, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Atelectasis

Study Results

No Results Posted as of Oct 18, 2019