Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

Not Applicable

Recruiting

• Conditions: Bronchiolitis
• Interventions: Device: Nasogastric tube placement

• Registration Number: NCT04480970
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Study Start: 2020-08-03
• Status Verified: 2022-07
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Primary Completion: 2024-04-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasogastric tube placement	Nasogastric tube placement	-

Primary Outcome Measures

Name	Time	Method
Respiratory status	60 minutes	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.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States