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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy; Monitored Anesthesia Care; Nasopharyngeal Airway
• Intervention / Treatment: Device: Nasopharyngeal airway

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.

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Christian Rouphael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Nasopharyngeal airway with 5L/min oxygen through nasal cannula	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; 5 L/min oxygen through nasal cannula alone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the procedure	Duration of the procedure in minutes	During the procedure
Total amount of Propofol	Total amount of Propofol in mg	During the procedure

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Christian Rouphael, MD, American University of Beirut Medical center; Principal Investigator: Rony Al Nawar, MD, LAU Medical Center-Rizk Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2018-0549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No