Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite

Morbid Obesity Clinical Trial

Official title:

Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859597
• Other study ID #: 2016-6677
• Status: Completed
• Phase: N/A
• Start date: December 28, 2016
• Est. completion date: September 28, 2018

Study information

• Verified date: April 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Morbid Obesity
• Noninvasive Ventilation
• Obesity, Morbid

Intervention

Device:
• High flow nasal cannula
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
• Nasal Cannula
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Berzin TM, Sanaka S, Barnett SR, Sundar E, Sepe PS, Jakubowski M, Pleskow DK, Chuttani R, Sawhney MS. A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administered sedation. Gastrointest Endosc. 2011 Apr;73(4):710-7. doi: 10.1016/j.gie.2010.12.011. Epub 2011 Feb 12. — View Citation

Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9. — View Citation

Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. — View Citation

Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577. Review. — View Citation

Rigg JD, Watt TC, Tweedle DE, Martin DF. Oxygen saturation during endoscopic retrograde cholangiopancreatography: a comparison of two protocols of oxygen administration. Gut. 1994 Mar;35(3):408-11. — View Citation

Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy, Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to Maintain Oxygenation	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.	During the period of sedation, on average up to 1 hour
Secondary	Number of Participants Requiring Airway Adjuncts During Procedure	The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.	During the period of sedation, on average up to 1 hour
Secondary	Number of Participants Who Need an Increase in Fraction of Inspired Oxygen	Need to increase the FiO2 to maintain adequate oxygenation	During period of sedation, on average up to 1 hour