Gastric US in ICU Patient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDartmouth-Hitchcock Medical Center
About this trial
This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.
Disqualifiers
Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.
Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.
Trial design
Design model
Parallel
Treatments tested in this trial
Gastric Ultrasound
Diagnostic testGastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard ASA NPO ProtocolExperimental treatment 1 intervention
Group B: Liberal Feeding ProtocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gastric Residual Volumes
Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.
Time frame
Within one hour of operative intervention.Secondary outcomes
1
Comparison of two different NPO protocol populations
Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).
Time frame
Within four months of study completion, 16 months from study start2
Peri-operative aspiration events
Number of aspiration events per number of operative interventions.
Time frame
Within four months of study completion, 16 months from study start3
Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
Calculation of enteral nutrition held during NPO time in kilocalories.
Time frame
Zero to sixteen hours prior to surgerySponsors and contacts
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Source ClinicalTrials.gov