Oxygen Concentration During Alveolar Recruitment

Not Applicable

Completed

• Conditions: Atelectasis, Postoperative Pulmonary
• Interventions: Procedure: FiO2_1.0; Procedure: FiO2_0.4

• Registration Number: NCT03943433
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2019-05-15
• Primary Completion: 2020-03-20
• Status Verified: 2020-07
• Study Completion: 2020-07-10
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

Exclusion Criteria

• American Society of Anesthesiologists physical status IV or more
• Severe cardiovascular disease
• Severe chronic obstructive pulmonary disease, emphysema
• History of pneumothorax, bullae
• History of lung resection surgery
• Conversion to laparotomy
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FiO2_1.0	FiO2_1.0	Alveolar recruitment is performed with 100% oxygen concentration at specific time points.
FiO2_0.4	FiO2_0.4	Alveolar recruitment is performed with 40% oxygen concentration at specific time points.

Primary Outcome Measures

Name	Time	Method
Modified lung ultrasound score	Intraoperative (at the end of operation, before emergence)	The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)\~3 (severe atelectasis), so the maximum total score is 36.

Secondary Outcome Measures

Name	Time	Method
Modified lung ultrasound score	Postoperative 30 minutes	The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)\~3 (severe atelectasis), so the maximum total score is 36.
Intraoperative desaturation	Intraoperative	Oxygen saturation by pulse oximetry \<95%
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Intraoperative (20minutes after each recruitment)	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Postoperative 30 minutes	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative pulmonary complication	Postoperative 24 hours	respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of