Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasogastric tube placement
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
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 prematurity (<37 weeks gestational age)
- History of chronic lung disease
- History of congenital heart disease
- History of G-tube dependence
- History of short gut syndrome
- History of tracheostomy or current tracheostomy
Sites / Locations
- Arkansas Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nasogastric tube placement
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04480970
First Posted
July 17, 2020
Last Updated
February 21, 2023
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04480970
Brief Title
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
Official Title
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasogastric tube placement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nasogastric tube placement
Intervention Description
All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.
Primary Outcome Measure Information:
Title
Respiratory status
Description
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.
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leroy Crawley, MS
Phone
5013643481
Email
crawleylj@archildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiro, MD, MPH
Organizational Affiliation
AR Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leroy Crawley, MS
Phone
501-364-3481
Email
crawleylj@archildrens.org
First Name & Middle Initial & Last Name & Degree
David Spiro, MD, MPH
Phone
5013641050
Email
dmspiro@uams.edu
12. IPD Sharing Statement
Learn more about this trial
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
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