Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding
Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding
Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus,
 stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding.
 However, blood clots often make visualization difficult during endoscopy. The current
 practice is to try to wash off and suction up these blood clots with the endoscope. However,
 this is often not successful due to blood clots blocking the suction channel.

 A new device has been approved by Health Canada that attaches to the endoscope and helps
 prevent blockage. It is believed that this device will help doctors suck out blood clots and
 potentially improve visualization, identification of the cause of bleeding, and possibly
 health outcomes, although this has never been proven. The purpose of the this clinical trial
 is to test whether the device works and whether it can help patients with this type of
 bleeding.
STUDY DESIGN:

 This is a randomized double blind clinical trial of the BioVac suction device versus standard
 endoscopy suction for UGIB. The study will be performed at London Health Sciences Center
 Victoria Campus and University Campus with an anticipated recruitment period of 2.5 years.

 STUDY POPULATION:

 All patients over the age of 18 admitted to hospital with a diagnosis of UGIB will be
 considered for recruitment. Patients already admitted to hospital with another diagnosis who
 develop UGIB will also be included.

 INTERVENTION:

 Patients will undergo EGD for UGIB as per standard clinical practice. If the bleeding source
 is not found within the first 5 minutes (timer starts once EGD passes upper esophageal
 sphincter) due to blood clots, the patient may benefit from additional suctioning. The
 patient will be randomized in blocks of 2-6 stratified by site to either the BioVac device or
 endoscopy suction. Those randomized to the BioVac device will use it to irrigate and suction
 as much blood as possible until the bleeding source is found or until the endoscopist feels
 that additional time would not help. Those randomized to endoscopy suction will do the same
 without the BioVac device. Due to the suctioning power of the study device, a placebo is not
 possible. Our original intention was to record the endoscopy video to blindly assess the
 outcome. Unfortunately, this ended up not being possible for technical reasons.
Inclusion Criteria

 1. Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena

 2. Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or
 tachycardia (heart rate > 110 beats per minute)

 Exclusion Criteria

 1. Identification of a bleeding source within the first 5 minutes of the upper endoscopy
 or no blood seen in the upper GI tract as these patients do not require additional
 suctioning.

 2. Age < 18.

 3. No endoscopy was performed.

 4. Endoscopy previously performed for current episode of UGIB.

 5. Patients unable to consent and who do not have a substitute decision maker.