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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03282032
Other study ID # JHSeo_preconditioning
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2017
Est. completion date October 13, 2018

Study information

Verified date August 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date October 13, 2018
Est. primary completion date October 9, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of hypoxemia SpO2 < 95% during one-lung ventilation, up to 5 hours
Primary P/F ratio PaO2/FIO2 ratio 30min after surgical incision
Secondary Pulmonary complications Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia 6, 24, 48 hours after surgery, during hospital stay.
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