NCT04918277

Brief Summary

In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

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

June 3, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

June 3, 2021

Last Update Submit

June 7, 2021

Conditions

Aspiration, RespiratoryCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • gastric volume

    Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months)

    preoperative 1 days to postoperative 1 days

Secondary Outcomes (1)

  • Grade of gastric fullness

    preoperative 1 days to postoperative 1 days

Interventions

Assessment of gastric volumeDEVICE

Measuring the cross-sectional area of stomach in supine and right lateral decubitus

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

You may qualify if:

  • Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

You may not qualify if:

  • Levin tube or gastrostomy tube in situ
  • Decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.

    PMID: 25495405BACKGROUND

MeSH Terms

Conditions

Respiratory AspirationCerebral Palsy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

June 5, 2021

Primary Completion

May 30, 2022

Study Completion

August 30, 2022

Last Updated

June 8, 2021

Record last verified: 2021-06