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NCT02851238 Clinical Trial

Driving Pressure and Postoperative Pulmonary Complications

One-Lung Ventilation Clinical Trial

Official title:
Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02851238
Other study ID # SMC 2016-05-107-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2016
Est. completion date September 1, 2017

Study information
Verified date October 2018
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Recruitment information / eligibility
Status Completed
Enrollment 312
Est. completion date September 1, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Adults greater than or equal to 19 years

- Patient who undergoes one-lung ventilation for thoracic surgery

Exclusion Criteria:

- The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4

- Patient who is contraindicated with application of positive end expiratory pressure

- Patient who rejects being enrolled in the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Driving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation

Locations
Country Name City State
Korea, Republic of Samsung medical center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of postoperative pulmonary complications Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale. within the first 3 days after surgery
Secondary Partial pressure of oxygen in arterial blood during surgery
Secondary The ratio of partial pressure arterial oxygen and fraction of inspired oxygen The ratio will be obtained from the first arterial blood gas analysis on the first postoperative day. on the first postoperative day
See also
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