Positive End-expiratory Pressure and Alveolar Recruitment for One Lung Ventilation

One Lung Ventilation Clinical Trial

Official title:

Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652612
• Other study ID #: 4-2011-0301
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: July 3, 2013
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .

Description:

outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA I-II

• age: 20-75 years

Exclusion Criteria:

• moderate to severe impaired respiratory function,

• heart failure,

• patients' refusal

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• One Lung Ventilation

Intervention

Other:
• PEEP
8 cmH2O PEEP throughout the period of OLV and 2nd TLV

Locations

Country	Name	City	State
Korea, Republic of	Yong Seon Choi	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2, number of patients with hypoxia (PaO2< 90mmHg)	blood samplings after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV	participants will be followed for the duration of anesthesia, an expected average of 3 hours	Yes
Secondary	intrapulmonary shunt	blood sampling after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV	participants will be followed for the duration of anesthesia, an expected average of 3 hours	No