NCT06650787

Brief Summary

Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

December 12, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

1.6 years

First QC Date

October 18, 2024

Last Update Submit

November 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of accurate gastric tube placement

    Accuracy of gastric tube placement is defined as proportion of accurate gastric tube placement (The tip of the nasogastric tube is positioned within the body or antrum of the stomach).

    The gastric tube is placed within ten minutes

Study Arms (2)

According to the ultrasonic images give into stomach tube group

EXPERIMENTAL

According to the ultrasonic images give into stomach tube group

Other: Ultrasound was used to locate the end of the gastric tube

Conventional placing nasogastric tube group

ACTIVE COMPARATOR

Conventional placing nasogastric tube group

Other: Conventional placing nasogastric tube group

Interventions

1. Inform the family of the purpose and method of using bedside ultrasound to guide the placement of the gastric tube, and determine the position of the end of the tube. 2. The ultrasound machine was connected to the power supply and placed on the right side of the patient. 3. Select the appropriate type of gastric tube and measure the length of the indwelling gastric tube by nursing staff before inserting the tube. 4. Nurses who had been trained in ultrasound performed ultrasound judgment on the neck and abdomen of the children. Sonographers, intensive care physicians and nursing staff jointly judged the ultrasound images. 5. Conventional judgment method was used to determine the position of gastric tube 6. Bedside chest radiography, with results obtained by a radiologist. 7. Keep your child safe at all times.

According to the ultrasonic images give into stomach tube group

1. Choose the appropriate type of gastric tube, and measure the length of the indwelling gastric tube by the nursing staff before the tube insertion. 2. The gastric tube was inserted by the conventional blind insertion method. 3. The conventional judgment method was used to determine the position of the gastric tube. 4. Bedside chest radiography, with results obtained by a radiologist. 5. Keep your child safe at all times.

Conventional placing nasogastric tube group

Eligibility Criteria

Age1 Day - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with CHD who needed gastric tube in CCU were admitted
  • children aged 0-6 years
  • Informed consent of parents

You may not qualify if:

  • Children with delayed sternal closure
  • The parents had cognitive impairment and mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CICU,Cardiovascular Center,Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 21, 2024

Study Start

December 12, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations