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

NCT ID: NCT04123821

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2023-11-08

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.

Conditions

Monitored Anesthesia Care; Gastrointestinal Endoscopy; Nasopharyngeal Airway

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

Nasopharyngeal airway with 5L/min oxygen through nasal cannula

Group Type: EXPERIMENTAL

Nasopharyngeal airway

Intervention Type: DEVICE

A disposable nasopharyngeal airway of appropriate size will be selected for patients allocated to the intervention group with 5L/min oxygen through nasal cannula

Group B

5 L/min oxygen through nasal cannula alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christian Rouphael

Instructor of Clinical Specialty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Rouphael, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Rony Al Nawar, MD

Role: PRINCIPAL_INVESTIGATOR

LAU Medical Center-Rizk Hospital

Locations

Christian Rouphael

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

BIO-2018-0549

Identifier Type: -

Identifier Source: org_study_id