NCT03439007

Brief Summary

The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index \[PI\], pleth variability index \[PVI\], pulse oximetry plethysmographic variance \[ΔPOP\]) can best predict hypotension during induction of anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

January 27, 2018

Last Update Submit

April 11, 2019

Conditions

Hypotension on Induction

Keywords

Dehydration

Outcome Measures

Primary Outcomes (1)

  • Pleth variability index

    pleth variability index

    changes for 10 minutes

Secondary Outcomes (7)

  • Adverse event_1

    10 minutes

  • Adverse event_2

    10 minutes

  • Adverse event_3

    10 minutes

  • Adverse event_4

    10 minutes

  • Heart rate

    changes for 10 minutes

  • +2 more secondary outcomes

Study Arms (2)

Hypotensive

A group of pediatric patients who showed hypotension during induction of anesthesia

Normotensive

A group of pediatric patients who did not show hypotension during induction of anesthesia

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 3-6 years

You may qualify if:

  • Children aged 3-6 years
  • Scheduled to undergo elective surgery under general anesthesia

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification III or more
  • Contraindication of laryngeal mask airway (LMA) insertion:
  • (1) Esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index \[BMI\] \> 30, expected anesthesia time \> 2 hours)
  • Arrhythmia
  • Left ventricular failure (ejection fraction \< 40%)
  • Congenital syndromes which are known to affect cardiopulmonary function
  • Use of inotropics/vasopressors before anesthesia
  • History of allergic reaction to drugs used in general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hee-Soo Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 27, 2018

First Posted

February 20, 2018

Study Start

February 10, 2018

Primary Completion

October 30, 2018

Study Completion

December 1, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

KR(1)