Preconditioning of One-lung Ventilation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03282032
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
One Lung Ventilation	Other: One-lung ventilation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preconditioning of One-lung Ventilation for Lung Protection
• Actual Study Start Date: Nov 22, 2017
• Actual Primary Completion Date: Oct 9, 2018
• Actual Study Completion Date: Oct 13, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of hypoxemia [during one-lung ventilation, up to 5 hours]

   SpO2 < 95%

2. P/F ratio [30min after surgical incision]

   PaO2/FIO2 ratio

Secondary Outcome Measures

1. Pulmonary complications [6, 24, 48 hours after surgery, during hospital stay.]

   Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404.

• Responsible Party: Jeong-Hwa Seo, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03282032
• Other Study ID Numbers: JHSeo_preconditioning
• First Posted: Sep 13, 2017
• Last Update Posted: Nov 30, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 30, 2018