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NCT04480970 Clinical Trial

Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04480970
Other study ID # IRB 261122
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 3, 2020
Est. completion date July 1, 2025

Study information
Verified date July 2022
Source Arkansas Children's Hospital Research Institute
Contact Leroy Crawley, MS
Phone 5013643481
Email crawleylj@archildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate whether placing nasogastric tubes for gastric decompression improves respiratory distress for patients with bronchiolitis who are receiving oxygen via high-flow nasal cannula.

Description:

All patients will be consented per IRB procedure. The study will be a prospective study. Study participants will be enrolled after placement on high flow nasal cannula. The respiratory therapist or study staff will use a bronchiolitis scoring tool, the Marlais Risk of Admission Score, to assess the respiratory status of patients after placement on high flow nasal cannula, and prior to placement of NG tube to establish a baseline measurement. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness. An NG tube will then be placed. Thirty minutes and sixty minutes after placement of the NG tube, the respiratory therapist or study team will again use this scoring tool to assess the respiratory status of the patient. After 60 minutes the study will be concluded. As subject will be requiring oxygen use, admission to an inpatient unit is required. The NG tube will be removed at the discretion of the provider or the admitting physician, who may choose to keep it in at their discretion.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 1, 2025
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 23 Months
Eligibility Inclusion Criteria: - Diagnosis of bronchiolitis by the attending physician - On high flow nasal cannula (4 liters or greater) - Ages 0 months to 23 months Exclusion Criteria: - Diagnosis of bacterial pneumonia - History of cranio-facial anomalies - History of congenital heart disease - History of G-tube dependence - History of short gut syndrome - History of tracheostomy or current tracheostomy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nasogastric tube placement
All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.

Locations
Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory status A bronchiolitis scoring tool, the Marlais Risk of Admission Score, will be used to assess the respiratory status of patients. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness. 60 minutes
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