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

American University of Beirut Medical Center

Status

Completed

Conditions

Gastrointestinal Endoscopy

Monitored Anesthesia Care

Nasopharyngeal Airway

Treatments

Device: Nasopharyngeal airway

Study type

Interventional

Funder types

Other

Identifiers

NCT04123821

BIO-2018-0549

Details and patient eligibility

About

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.

Full description

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.

Enrollment

334 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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