Back to resultsLung Recruitment Maneuver for Predicting Fluid Responsiveness in Children
Primary Purpose
Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lung recruitment maneuver
Sponsored by
About this trial
This is an interventional other trial for Hypovolemia
Eligibility Criteria
Inclusion Criteria:
- pediatric patients undergoing general anesthesia under 6 years old
Exclusion Criteria:
- arrhythmia
- <30%, ejection fraction
- lung disease
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lung recruitment maneuver
Arm Description
Heart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value. Cardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%.
Outcomes
Primary Outcome Measures
photoplethysmographic waveform
Secondary Outcome Measures
Full Information
NCT ID
NCT03184961
First Posted
June 8, 2017
Last Updated
May 27, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03184961
Brief Title
Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children
Official Title
Study on Variables Able to Predict Fluid Responsiveness Using Lung Recruitment Maneuver in Pediatric Patients Undergoing General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University 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
Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lung recruitment maneuver
Arm Type
Experimental
Arm Description
Heart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value.
Cardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%.
Intervention Type
Diagnostic Test
Intervention Name(s)
lung recruitment maneuver
Intervention Description
Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)
Primary Outcome Measure Information:
Title
photoplethysmographic waveform
Time Frame
change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pediatric patients undergoing general anesthesia under 6 years old
Exclusion Criteria:
arrhythmia
<30%, ejection fraction
lung disease
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33186310
Citation
Kim EH, Lee JH, Jang YE, Ji SH, Kim HS, Cho SA, Kim JT. Prediction of fluid responsiveness using lung recruitment manoeuvre in paediatric patients receiving lung-protective ventilation: A prospective observational study. Eur J Anaesthesiol. 2021 May 1;38(5):452-458. doi: 10.1097/EJA.0000000000001387.
Results Reference
derived
Learn more about this trial
Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children
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