Brief Summary
This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.
Brief Title
Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite
Detailed Description
The respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. In addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. Both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. However, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm H2O of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Morbid Obesity
Noninvasive Ventilation
Deep Sedation
Eligibility Criteria
Inclusion Criteria:
* Body Mass Index greater than or equal to 40
* Scheduled for a gastrointestinal endoscopy that requires MAC sedation
Exclusion Criteria:
* Body Mass Index less than 40
* Pregnant
* Require either invasive or non-invasive ventilation for respiratory failure
* Use home oxygen
* Ventilation is via a tracheostomy
* The procedure is emergent
* Body Mass Index greater than or equal to 40
* Scheduled for a gastrointestinal endoscopy that requires MAC sedation
Exclusion Criteria:
* Body Mass Index less than 40
* Pregnant
* Require either invasive or non-invasive ventilation for respiratory failure
* Use home oxygen
* Ventilation is via a tracheostomy
* The procedure is emergent
Inclusion Criteria
Inclusion Criteria:
* Body Mass Index greater than or equal to 40
* Scheduled for a gastrointestinal endoscopy that requires MAC sedation
* Body Mass Index greater than or equal to 40
* Scheduled for a gastrointestinal endoscopy that requires MAC sedation
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02859597
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6677
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite
Primary Outcomes
Outcome Description
The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.
Outcome Measure
Ability to Maintain Oxygenation
Outcome Time Frame
During the period of sedation, on average up to 1 hour
Secondary Outcomes
Outcome Description
The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.
Outcome Time Frame
During the period of sedation, on average up to 1 hour
Outcome Measure
Number of Participants Requiring Airway Adjuncts During Procedure
Outcome Description
Need to increase the FiO2 to maintain adequate oxygenation
Outcome Time Frame
During period of sedation, on average up to 1 hour
Outcome Measure
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jay Berger
Investigator Email
jberger@montefiore.org
Investigator Phone