Optimal Level of PEEP in Protective One-lung Ventilation

Video-assisted Thoracic Surgery Clinical Trial

Official title:

Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856918
• Other study ID #: H-1901-086-1004
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 28, 2021
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion Criteria:

• Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test

• Chronic kidney disease

• Coronary artery disease

• Pulmonary hypertension

• Bilateral lung surgery

• Conversion to thoracotomy

• American Society of Anesthesiologists physical status IV or more

• Refusal to participate

Related Conditions & MeSH terms

• Positive End-expiratory Pressure
• Postoperative Atelectasis
• Pulmonary Atelectasis
• Video-assisted Thoracic Surgery

Intervention

Procedure:
• PEEP 3 cm of water
PEEP of 3 cm of water will be applied during one-lung ventilation.
• PEEP 6 cm of water
PEEP of 6 cm of water will be applied during one-lung ventilation.
• PEEP 9 cm of water
PEEP of 9 cm of water will be applied during one-lung ventilation.

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.	Postoperative 1 hour
Secondary	Intraoperative desaturation	Oxygen saturation by pulse oximetry <95% during one-lung ventilation	Average time of 60-90 minutes
Secondary	Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio	partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation	Average time of 60-90 minutes
Secondary	Postoperative desaturation	Oxygen saturation by pulse oximetry <95%	Postoperative 24 hours
Secondary	plasma Tumor Necrosis Factor-a	proinflammatory cytokine	10 minutes after initiation of one-lung ventilation
Secondary	plasma Interleukin-6	proinflammatory cytokine	10 minutes after initiation of one-lung ventilation
Secondary	plasma Interleukin-10	anti-inflammatory cytokine	10 minutes after initiation of one-lung ventilation
Secondary	Postoperative pulmonary complication	Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration	Postoperative 7 days