Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation

NCT ID: NCT03794414

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-06-26

Brief Summary

The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation.

Detailed Description

Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. The aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid responsiveness.

The investigators hypothesized that applying PEEP in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.

Conditions

Lung Cancer; Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

fluid responder

patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.

Group Type: EXPERIMENTAL

PEEP challenge

Intervention Type: PROCEDURE

apply PEEP 10 mmHg in one-lung ventilating patients.

fluid non-responder

patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge

Group Type: EXPERIMENTAL

PEEP challenge

Intervention Type: PROCEDURE

apply PEEP 10 mmHg in one-lung ventilating patients.

Interventions

PEEP challenge

apply PEEP 10 mmHg in one-lung ventilating patients.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients undergoing lung surgery under one-lung ventilation

Exclusion Criteria

• arrhythmia
• moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction < 40%
• moderate to severe chronic obstructive lung disease
• unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy )
• patient refusal
• cannot understand the protocol
• less than 50kg or over 100kg in weight

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Choi Eun MI

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun-mi Choi, Professor

Role: STUDY_CHAIR

Kangnam Sungshim Hospital

Locations

Kangnam Sungshim Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2018-11-028

Identifier Type: -

Identifier Source: org_study_id