The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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The goal of this prospective, multi-center, single-blinded randomized controlled trial is to assess the efficacy of NPA in reducing respiratory events in patients being admitted for GI endoscopy (colonoscopy, gastroscopy, endoscopic ultrasound) under deep sedation. The main question it aims to answer are: • [Is the NPA used on patients undergoing gastrointestinal endoscopy efficient in reducing respiratory events?] Participants will be randomly allocated into one of the two groups: NPA with 5L/min oxygen through nasal cannula (group A) or 5 L/min oxygen through nasal cannula alone (group B). Researchers will compare NPA group to nasal cannula group to see if the routine placement of an NPA can reduce the frequency of airway obstruction, hypoxemic events and airway maneuvers (chin lift, oral airway insertion, and mask-bag ventilation) during endoscopic sedation.

Detailed Description
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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 (NPA) is a simple device that can be conveniently inserted into the supraglottic airway to secure an open passage. This is a prospective, multi-center, single-blinded randomized controlled trial designed to evaluate the efficacy of the routine use of NPA 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 NPA (group A) or nasal cannula 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.

Official Title
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The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy: A Multi-center Randomized Controlled Trial

Conditions
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Monitored Anesthesia Care, Gastrointestinal Endoscopy, Nasopharyngeal Airway

Intervention / Treatment
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* Device: Nasopharyngeal airway


Participation Criteria
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Eligibility Criteria
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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: Patients with craniofacial abnormalities Patients with a history of recent nasal or cranial bone fracture Patients with a history of recent nasal or trans-sphenoidal surgery Patients with nasal polyposis Patients with a history of epistaxis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Nasopharyngeal airway with 5L/min oxygen through nasal cannula | Device: Nasopharyngeal airway<br>* A disposable nasopharyngeal airway of appropriate size will be selected for patients allocated to the intervention group with 5L/min oxygen through nasal cannula<br>|
| No Intervention: Group B<br>5 L/min oxygen through nasal cannula alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Respiratory events (desaturation) | oxygen saturation (%) | During the procedure | 
| Incidence of Respiratory events (chin lift) | Occurrence of the event (chin lift):yes or no and the number of episodes if yes | During the procedure | 
| Incidence of Respiratory events (jaw thrust) | Occurrence of the event (jaw thrust):yes or no and the number of episodes if yes | During the procedure | 
| Incidence of Respiratory events (mask-bag ventilation) | Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guedel airway insertion | Occurrence of the event (Guedel airway insertion): yes or no and the number of episodes if yes | During the procedure | 
| LMA insertion | Occurrence of the event (LMA insertion): yes or no and the number of episodes if yes | During the procedure | 
| Intubation | Occurrence of the event (intubation): yes or no and the number of episodes if yes | During the procedure | 
| Interruptions during the case | Occurrence of the event (Interruptions during the case): yes or no and the number of episodes if yes | During the procedure | 
| Incidence of hypotension | Occurrence of the event (SBP<90 mmHg): yes or no and the number of episodes if yes | During the procedure | 
| Bradycardia | Occurrence of the event (HR<50 beats/min): yes or no and the number of episodes if yes | During the procedure | 
| Epistaxis | Development of epistaxis: yes or no and the number of episodes if yes | During the procedure | 
| Cough | Development of cough: yes or no and the number of episodes if yes | During the procedure | 
| Laryngospasm | Development of laryngospasm: yes or no and the number of episodes if yes | During the procedure | 
| Bronchospasm | Development of bronchospasm: yes or no and the number of episodes if yes | During the procedure | 
| Movement impeding procedure | Patient's movement impeded the procedure :yes or no and the number of episodes if yes | During the procedure | 
| Satisfaction score of the anesthesiologist | Satisfaction score of the anesthesiologist on a numerical rating scale from 0 to 10 | Up to 2 hours after the procedure | 
| Satisfaction score of the proceduralist | Satisfaction score of the proceduralist on a numerical rating scale from 0 to 10 | Up to 2 hours after the procedure | 
| Satisfaction score of the patient | Satisfaction score of the patient on a numerical rating scale from 0 to 10 | Up to 2 hours after the procedure |