Clinical trial NCT04123821: The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy
Official title: The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monitored Anesthesia Care
Gastrointestinal Endoscopy
Nasopharyngeal Airway
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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:

* 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

Primary outcomes:
measure: Incidence of Respiratory events (desaturation)
timeFrame: During the procedure
measure: Incidence of Respiratory events (chin lift/jaw thrust)
timeFrame: During the procedure
measure: Incidence of Respiratory events (mask-bag ventilation)
timeFrame: During the procedure
Secondary outcomes:
measure: Intubation
timeFrame: During the procedure
measure: Interruptions during the case
timeFrame: During the procedure
measure: Incidence of hypotension
timeFrame: During the procedure
measure: Bradycardia
timeFrame: During the procedure
measure: Epistaxis
timeFrame: During the procedure
measure: Cough
timeFrame: During the procedure
measure: Laryngospasm
timeFrame: During the procedure
measure: Movement impeding procedure
timeFrame: During the procedure
measure: Satisfaction score of the anesthesiologist
timeFrame: Up to 2 hours after the procedure
measure: Satisfaction score of the proceduralist
timeFrame: Up to 2 hours after the procedure
measure: Satisfaction score of the patient
timeFrame: Up to 2 hours after the procedure
Other outcomes:
measure: Duration of the procedure
timeFrame: During the procedure
measure: Total amount of Propofol
timeFrame: During the procedure
Locations:
city: Beirut
country: Lebanon
facility: Christian Rouphael
Study officials:
affiliation: American University of Beirut Medical Center
name: Christian Rouphael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LAU Medical Center-Rizk Hospital
name: Rony Al Nawar, MD
role: PRINCIPAL_INVESTIGATOR
References: