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

Gastrointestinal Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123821
• Other study ID #: BIO-2018-0549
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: November 8, 2023

Study information

• Verified date: December 2023
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• Monitored Anesthesia Care
• Nasopharyngeal Airway

Intervention

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

Locations

Country	Name	City	State
Lebanon	Christian Rouphael	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of the procedure	Duration of the procedure in minutes	During the procedure
Other	Total amount of Propofol	Total amount of Propofol in mg	During the procedure
Primary	Incidence of Respiratory events (desaturation)	oxygen saturation (%)	During the procedure
Primary	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
Primary	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
Primary	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	Guedel airway insertion	Occurrence of the event (Guedel airway insertion): yes or no and the number of episodes if yes	During the procedure
Secondary	LMA insertion	Occurrence of the event (LMA insertion): yes or no and the number of episodes if yes	During the procedure
Secondary	Intubation	Occurrence of the event (intubation): yes or no and the number of episodes if yes	During the procedure
Secondary	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
Secondary	Incidence of hypotension	Occurrence of the event (SBP<90 mmHg): yes or no and the number of episodes if yes	During the procedure
Secondary	Bradycardia	Occurrence of the event (HR<50 beats/min): yes or no and the number of episodes if yes	During the procedure
Secondary	Epistaxis	Development of epistaxis: yes or no and the number of episodes if yes	During the procedure
Secondary	Cough	Development of cough: yes or no and the number of episodes if yes	During the procedure
Secondary	Laryngospasm	Development of laryngospasm: yes or no and the number of episodes if yes	During the procedure
Secondary	Bronchospasm	Development of bronchospasm: yes or no and the number of episodes if yes	During the procedure
Secondary	Movement impeding procedure	Patient's movement impeded the procedure :yes or no and the number of episodes if yes	During the procedure
Secondary	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
Secondary	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
Secondary	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