An interventional study of water in Respiratory Aspiration and Pregnancy, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable and Interventional
Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.
The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.
In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.
1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.
This study's enrollment of 60 is above the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
No fluid will be given to the patient prior to scanning.
50mL of water will be given to the patient prior to scanning
Other: water
100mL of water will be given to the patient prior to scanning
Other: water
200mL of water will be given to the patient prior to scanning
Other: water
300mL of water will be given to the patient prior to scanning
Other: water
400mL of water will be given to the patient prior to scanning
Other: water
water
Correlation between ingested volume and CSA in antrum
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
Time frame: 5-10 minutes
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital