Preconditioning of One-lung Ventilation
1 other identifier
interventional
136
1 country
1
Brief Summary
To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2018
CompletedNovember 30, 2018
August 1, 2018
11 months
September 8, 2017
November 28, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of hypoxemia
SpO2 \< 95%
during one-lung ventilation, up to 5 hours
P/F ratio
PaO2/FIO2 ratio
30min after surgical incision
Secondary Outcomes (1)
Pulmonary complications
6, 24, 48 hours after surgery, during hospital stay.
Study Arms (2)
One-lung ventilation
EXPERIMENTALBefore surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.
Two-lung ventilation
NO INTERVENTIONMaintain two-lung ventilation until surgical incision
Interventions
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.
Eligibility Criteria
You may qualify if:
- Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position
You may not qualify if:
- Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease
- Thoracic surgery for pneumonectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.
PMID: 6837992BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeong-Hwa Seo, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 8, 2017
First Posted
September 13, 2017
Study Start
November 22, 2017
Primary Completion
October 9, 2018
Study Completion
October 13, 2018
Last Updated
November 30, 2018
Record last verified: 2018-08