Preconditioning of One-lung Ventilation

Preconditioning of One-lung Ventilation for Lung Protection

To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.

Study Overview

• Status: Completed
• Conditions: One Lung Ventilation
• Intervention / Treatment: Other: One-lung ventilation

Detailed Description

For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia.

Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation.

Thus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

Exclusion Criteria:

• Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease
• Thoracic surgery for pneumonectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-lung ventilation; Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.	Other: One-lung ventilation; The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil. In the intervention group, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.; Other Names: Preconditioning
No Intervention: Two-lung ventilation; Maintain two-lung ventilation until surgical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	SpO2 < 95%	during one-lung ventilation, up to 5 hours
P/F ratio	PaO2/FIO2 ratio	30min after surgical incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary complications	Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia	6, 24, 48 hours after surgery, during hospital stay.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Jeong-Hwa Seo, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): October 13, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 10, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: JHSeo_preconditioning

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No