Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

NCT ID: NCT04480970

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2025-07-01

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasogastric tube placement

Group Type: EXPERIMENTAL

Nasogastric tube placement

Intervention Type: DEVICE

All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.

Interventions

Nasogastric tube placement

All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Spiro, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

AR Children's Hospital

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leroy Crawley, MS

Role: CONTACT

crawleylj@archildrens.org

5013643481

Facility Contacts

Leroy Crawley, MS

Role: primary

crawleylj@archildrens.org

501-364-3481

David Spiro, MD, MPH

Role: backup

dmspiro@uams.edu

5013641050

Other Identifiers

IRB 261122

Identifier Type: -

Identifier Source: org_study_id