Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2020-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

NCT01364103

Fluid Responsiveness

COMPLETED NA

Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

NCT02952651

Hypovolemia

COMPLETED NA

Anesthesia-induced Hypotension and Fluid Responsiveness

NCT03439007

Hypotension on Induction

COMPLETED

Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children

NCT02536521

Laparoscopic Surgery

COMPLETED

Preoperative Goal-directed Fluid Therapy and Physiological Changes Following One-lung Ventilation

NCT03064880

Therapy Adverse Effect

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.

The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.

In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.

Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.

With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plasma Volume Tidal Volume

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Measure pulse pressure variation and systolic pressure variation after each set of tidal volume to 6mL/kg, 10mL/kg and 14mL/kg. Measure respiratory variation of aortic blood flow peak velocity via transesophageal echocardiography at tidal volume of 10mL/kg.

Measure stroke volume index via transesophageal echocardiography before and 5 min after fluid loading with 10mL/kg of crystalloid.

Group Type EXPERIMENTAL

Tidal volume_6mL/kg

Intervention Type PROCEDURE

Set tidal volume to 6mL/kg for 1 minute

Tidal volume_10mL/kg

Intervention Type PROCEDURE

Set tidal volume to 10mL/kg for 1 minute

Tidal volume_14mL/kg

Intervention Type PROCEDURE

Set tidal volume to 10mL/kg for 1 minute

Fluid loading

Intervention Type PROCEDURE

Administer 10mL/kg of crystalloid for 5 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tidal volume_6mL/kg

Set tidal volume to 6mL/kg for 1 minute

Intervention Type PROCEDURE

Tidal volume_10mL/kg

Set tidal volume to 10mL/kg for 1 minute

Intervention Type PROCEDURE

Tidal volume_14mL/kg

Set tidal volume to 10mL/kg for 1 minute

Intervention Type PROCEDURE

Fluid loading

Administer 10mL/kg of crystalloid for 5 minutes

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia

Exclusion Criteria

* Children with other complex cardiac defects
* Children with arrhythmia
* Children with preoperatively measured ejection fraction of less than 30%
* Children with underlying pulmonary disease

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No