The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy
Study Details
Study Description
Brief Summary
Monitored anesthesia care (MAC) is currently the dominant method of endoscopic sedation for approximately one third of all US gastroenterologists. The popularity and success of MAC can be ascribed to many factors including increased patient turnover and improved patient satisfaction. Patients undergoing MAC maintain spontaneous breathing and routinely receive supplemental oxygen. In case of airway obstruction, additional airway adjuncts may be used such as supraglottic airway devices including oropharyngeal airway, nasopharyngeal airway, laryngeal mask, etc. A nasopharyngeal airway is a simple device that can be conveniently inserted into the supraglottic airway to secure an open passage. This is a randomized controlled trial designed to evaluate the efficacy of the routine use of nasopharyngeal airway in preventing airway obstruction during deep sedation. Patients undergoing gastrointestinal endoscopy under monitored anesthesia care using target-controlled infusion of propofol at AUBMC will be randomly and equally apportioned to the nasopharyngeal group (group A) or control group (group B). Episodes of desaturation, airway maneuvers, hemodynamic instability, adverse events related to NPA insertion, duration of the procedure, and the anesthetic dose will be recorded. The satisfaction of the anesthesiologist, gastroenterologist, and patient will be scored. The aim of this study is first to assess the efficacy of NPA in reducing respiratory events, and second, to identify the safety of this device as well as patient, gastroenterologist and anesthesiologist satisfaction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A
|
Device: Nasopharyngeal airway
A disposable nasopharyngeal airway of appropriate size will be selected for patients allocated to the intervention group with 5L/min oxygen through nasal cannula
|
| No Intervention: Group B
|
Outcome Measures
Primary Outcome Measures
- Incidence of Respiratory events (desaturation) [During the surgery]
oxygen saturation (%)
- Incidence of Respiratory events (chin lift) [During the surgery]
Occurrence of the event (chin lift):yes or no and the number of episodes if yes
- Incidence of Respiratory events (jaw thrust) [During the surgery]
Occurrence of the event (jaw thrust):yes or no and the number of episodes if yes
- Incidence of Respiratory events (mask-bag ventilation) [During the surgery]
Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes
Eligibility Criteria
Criteria
Inclusion criteria:
-
Patients undergoing GI endoscopy under MAC using TCI of Propofol
-
Patients above 18 years old
-
Patient able to give consent
-
ASA classification: I, II, III
Exclusion criteria:
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Patients with craniofacial abnormalities
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Patients with a history of recent nasal or cranial bone fracture
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Patients with a history of recent nasal or trans-sphenoidal surgery
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Patients with nasal polyposis
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Patients with a history of epistaxis
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Patients with a history of coagulopathy or on anticoagulation therapy (including patients on Aspirin not stopped 7 days prior to presentation)
-
Patients with a history of allergy to Xylometazoline or local anesthetics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Christine El-Yahchouchi | Beirut | Lebanon |
Sponsors and Collaborators
- American University of Beirut Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIO-2018-0549