Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

February 21, 2023 updated by: Arkansas Children's Hospital Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasogastric tube placement
Device: Nasogastric tube placement
All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory status
Time Frame: 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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: David Spiro, MD, MPH, AR Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 261122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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