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Clinical Trials/NCT03856918
NCT03856918CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country142 target enrollmentStarted: May 28, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
142
Locations
1
Primary Endpoint
Modified lung ultrasound score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

PEEP 3 cm of water

Experimental

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.

Intervention: PEEP 3 cm of water (Procedure)

PEEP 6 cm of water

Experimental

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.

Intervention: PEEP 6 cm of water (Procedure)

PEEP 9 cm of water

Experimental

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.

Intervention: PEEP 9 cm of water (Procedure)

Outcomes

Primary Outcomes

Modified lung ultrasound score

Time Frame: Postoperative 1 hour

The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.

Secondary Outcomes

  • plasma Tumor Necrosis Factor-α(10 minutes after initiation of one-lung ventilation)
  • Intraoperative desaturation(Average time of 60-90 minutes)
  • Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(Average time of 60-90 minutes)
  • Postoperative desaturation(Postoperative 24 hours)
  • plasma Interleukin-6(10 minutes after initiation of one-lung ventilation)
  • plasma Interleukin-10(10 minutes after initiation of one-lung ventilation)
  • Postoperative pulmonary complication(Postoperative 7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jae-Hyon Bahk, MD, PhD

Professor

Seoul National University Hospital

Study Sites (1)

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