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Gastric Ultrasound in Tube Fed Intubated Patients

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ClinicalTrials.gov Identifier: NCT04612348
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Description
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Brief Summary:
This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held prior to a procedure or if they need to be held at all. This would allow critically ill children to receive the nutrition that they need to heal for longer periods of time. Using ultrasound would also potentially eliminate the need for exposure to x-rays to confirm tube placement. Most ICUs have a POC ultrasound machine so this would be any easy tool to access to improve patient care.

Condition or disease Intervention/treatment
Critical Illness Diagnostic Test: Ultrasound

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Utility of POC Gastric Ultrasound in Confirming Stomach is Empty in Intubated Patients Fed Gastrically (NG) Versus Transpylorically (NJ) to Ensure Low Risk of Aspiration.
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
NJ tube fed
Critically ill children receiving nutrition via a nasojejunal feeding tube.
 Diagnostic Test: Ultrasound
Point of care ultrasound to measure gastric contents.
NG tube fed
Critically ill children receiving nutrition via a nasogastric feeding tube.
 Diagnostic Test: Ultrasound
Point of care ultrasound to measure gastric contents.


Outcome Measures
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Primary Outcome Measures :
  1. Gastric contents [ Time Frame: Baseline (Day 1) ]
    Amount of gastric contents measured by ultrasound.


Secondary Outcome Measures :
  1. Gastric contents [ Time Frame: Day 2 (if still intubated & being tube fed) ]
    Amount of gastric contents measured by ultrasound.

  2. Gastric contents [ Time Frame: Day 3 (if still intubated & being tube fed) ]
    Amount of gastric contents measured by ultrasound.

  3. Gastric contents [ Time Frame: Day 4 (if still intubated & being tube fed) ]
    Amount of gastric contents measured by ultrasound.

  4. Gastric contents [ Time Frame: Day 5 (if still intubated & being tube fed) ]
    Amount of gastric contents measured by ultrasound.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill children at Nationwide Children's Hospital
Criteria

Inclusion Criteria:

  • all PICU patients intubated < 7 days that are receiving NJ or NG feeds

Exclusion Criteria:

  • patients that cannot be moved
  • patients with significant GI conditions affecting motility
  • patients intubated for more than seven days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612348


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
Investigators
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Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital
More Information
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Responsible Party: Joseph D. Tobias, Chair, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT04612348    
Other Study ID Numbers: STUDY00001377
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes