Optimal Level of PEEP in Protective One-lung Ventilation

Not Applicable

Completed

• Conditions: Postoperative Atelectasis; Video-assisted Thoracic Surgery; Positive End-expiratory Pressure
• Interventions: Procedure: PEEP 6 cm of water; Procedure: PEEP 3 cm of water; Procedure: PEEP 9 cm of water

• Registration Number: NCT03856918
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Study Start: 2019-05-28
• Primary Completion: 2020-02-11
• Study Completion: 2021-02-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEP 6 cm of water	PEEP 6 cm of water	Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery.
PEEP 3 cm of water	PEEP 3 cm of water	Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery.
PEEP 9 cm of water	PEEP 9 cm of water	Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery.

Primary Outcome Measures

Name	Time	Method
Modified lung ultrasound score	Postoperative 1 hour	The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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