Oxygen Concentration During Alveolar Recruitment

Atelectasis, Postoperative Pulmonary Clinical Trial

Official title:

The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943433
• Other study ID #: JHBahk_AR
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 10, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis, Postoperative Pulmonary
• Pulmonary Atelectasis

Intervention

Procedure:
• FiO2_1.0
Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
• FiO2_0.4
Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.

Locations

Country	Name	City	State
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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified lung ultrasound score	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 (at the end of operation, before emergence)
Secondary	Modified lung ultrasound score	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.	Postoperative 30 minutes
Secondary	Intraoperative desaturation	Oxygen saturation by pulse oximetry <95%	Intraoperative
Secondary	Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Intraoperative (20minutes after each recruitment)
Secondary	Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Partial pressure of arterial oxygen/fraction of inspired oxygen ratio	Postoperative 30 minutes
Secondary	Postoperative pulmonary complication	respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis	Postoperative 24 hours