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NCT03607240 Clinical Trial

Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery

Pulmonary Atelectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03607240
Other study ID # H-1805-148-948
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2018
Est. completion date January 15, 2019

Study information
Verified date October 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 15, 2019
Est. primary completion date January 10, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• conventional alveolar recruitment
Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds

Locations
Country Name City State
Korea, Republic of Jin-Tae Kim Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary incidence of atelectasis diagnosed by ultrasonography the presence of atelectasis by ultrasonography intraoperative
Secondary arterial blood gas analyses PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2) intraoperative
Secondary 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
Secondary intraoperative mean arterial pressure mean arterial pressure in mmHg intraoperative
Secondary intraoperative SpO2 SpO2 in % intraoperative
Secondary intraoperative peak airway pressure peak airway pressure in cmH2O intraoperative
Secondary 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
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