Effects of Different I:E Ratio on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

Lung Cancer Clinical Trial

Official title:

Effects of Different Inspiratory to Expiratory Ratios on Intrapulmonary Shunt Fraction and Oxygenation During One Lung Ventilation in the Lateral Decubitus Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499212
• Other study ID #: 1-2011-0058
• Status: Completed
• Phase: N/A
• First received: December 18, 2011
• Last updated: December 21, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea:Korea food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.

Description:

Increasing inspiratory time(e.g. Inverse ratio ventilation) has been known that had advantage of alveolar recruitment, preventing of ateletasis. On the contrary, it has disadvantange of intrinsic PEEP, air trapping. There is few study on one lung ventilation in lateral decubitus position about this ventilation method. We were going to investigate effecf of this ventilation method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA physical status class I, II

• Use of Double lumen tube

• Unilateral lung lobectomy

Exclusion Criteria:

• COPD

• CAOD

• Unstable hemodynamic status

• Peak airway pressure > 30mmHg (Two lung ventilation)

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Lobectomy

Intervention

Procedure:
• I:E ratio
I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	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	intrapulmonary shunt fraction	T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt	T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation)	Yes
Secondary	Respiratory dynamic parameters	Mechanical Ventilator measurement : Paw, Pplat, Pmean, Compliance	T1,T2,T3,T4 (same as primary outcome measure)	Yes