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

NCT04123821 | Completed

• 1 other identifier: BIO-2018-0549
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitored Anesthesia Care; Gastrointestinal Endoscopy; Nasopharyngeal Airway

Outcome Measures

Primary Outcomes (3)

• Incidence of Respiratory events (desaturation)

  oxygen saturation (%)

  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

• 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 Outcomes (11)

• Intubation

  During the procedure

• Interruptions during the case

  During the procedure

• Incidence of hypotension

  During the procedure

• Bradycardia

  During the procedure

• Epistaxis

  During the procedure

Other Outcomes (2)

• Duration of the procedure

  During the procedure

• Total amount of Propofol

  During the procedure

Study Arms (2)

Group A

EXPERIMENTAL

Nasopharyngeal airway with 5L/min oxygen through nasal cannula

Device: Nasopharyngeal airway

Group B

NO INTERVENTION

5 L/min oxygen through nasal cannula alone

Interventions

Nasopharyngeal airway 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 A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Christian Rouphael

Beirut, Lebanon

Location

Study Officials

• Christian Rouphael, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

• Rony Al Nawar, MD

  LAU Medical Center-Rizk Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Clinical Specialty

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 11, 2019
• Study Start: November 11, 2019
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

LE (1)