Gastric US in ICU Patient

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols

Conditions
-----------------
Critical Illness, Surgery, Aspiration Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: Gastric Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard ASA NPO Protocol<br>Patients will be made NPO at midnight prior to date of surgery. | Diagnostic Test: Gastric Ultrasound<br>* Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.<br>|
| Experimental: Liberal Feeding Protocol<br>Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube. | Diagnostic Test: Gastric Ultrasound<br>* Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within one hour of operative intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Within four months of study completion, 16 months from study start | 
| Peri-operative aspiration events | Number of aspiration events per number of operative interventions. | Within four months of study completion, 16 months from study start | 
| 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. | Zero to sixteen hours prior to surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPO Protocols, Intensive Care Unit, Gastric Ultrasound, Ultrasound, Surgical Intensive Care Unit, NPO, Nasogastric Tube, Orogastric Tube, Enteral Nutrition, Parenteral Nutrition, Gastric Residual Volume, Aspiration, Critical Illness Nutrition