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Preconditioning of One-lung Ventilation

NCT ID: NCT03282032

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2018-10-13

Brief Summary

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

Detailed Description

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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

Conditions

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One Lung Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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One-lung ventilation

Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.

Group Type EXPERIMENTAL

One-lung ventilation

Intervention Type OTHER

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.

Two-lung ventilation

Maintain two-lung ventilation until surgical incision

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Preconditioning

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Hwa Seo, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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

Reference Type BACKGROUND
PMID: 6837992 (View on PubMed)

Other Identifiers

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JHSeo_preconditioning

Identifier Type: -

Identifier Source: org_study_id