NCT03184961

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

June 8, 2017

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • photoplethysmographic waveform

    change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds

Study Arms (1)

lung recruitment maneuver

EXPERIMENTAL

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%.

Diagnostic Test: lung recruitment maneuver

Interventions

Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)

lung recruitment maneuver

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients undergoing general anesthesia under 6 years old

You may not qualify if:

  • arrhythmia
  • \<30%, ejection fraction
  • lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 14, 2017

Study Start

June 15, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations