Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
Primary Purpose
Lung Cancer, Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP challenge
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
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
Sites / Locations
- Kangnam Sungshim Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
fluid responder
fluid non-responder
Arm Description
patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.
patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge
Outcomes
Primary Outcome Measures
pulse pressure variation
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
Secondary Outcome Measures
stroke volume variation
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.
Full Information
NCT ID
NCT03794414
First Posted
January 3, 2019
Last Updated
July 26, 2020
Sponsor
Hallym University Kangnam Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03794414
Brief Title
Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
Official Title
The Influence of Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluid responder
Arm Type
Experimental
Arm Description
patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.
Arm Title
fluid non-responder
Arm Type
Experimental
Arm Description
patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge
Intervention Type
Procedure
Intervention Name(s)
PEEP challenge
Intervention Description
apply PEEP 10 mmHg in one-lung ventilating patients.
Primary Outcome Measure Information:
Title
pulse pressure variation
Description
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
Time Frame
5 minutes after PEEP challenge
Secondary Outcome Measure Information:
Title
stroke volume variation
Description
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.
Time Frame
5 minutes after PEEP challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun-mi Choi, Professor
Organizational Affiliation
Kangnam Sungshim Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangnam Sungshim Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
However, I can always share if required.
Learn more about this trial
Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
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