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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04123821
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Information provided by (Responsible Party):
Christine El Yahchouchi, American University of Beirut Medical Center

Brief Summary:
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 is a simple device that can be conveniently inserted into the supraglottic airway to secure an open passage. This is a randomized controlled trial designed to evaluate the efficacy of the routine use of nasopharyngeal airway 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 nasopharyngeal group (group A) or control 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.

Condition or disease Intervention/treatment Phase
Monitored Anesthesia Care Gastrointestinal Endoscopy Nasopharyngeal Airway Device: Nasopharyngeal airway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Group A 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

Primary Outcome Measures :
  1. Incidence of Respiratory events (desaturation) [ Time Frame: During the surgery ]
    oxygen saturation (%)

  2. Incidence of Respiratory events (chin lift) [ Time Frame: During the surgery ]
    Occurrence of the event (chin lift):yes or no and the number of episodes if yes

  3. Incidence of Respiratory events (jaw thrust) [ Time Frame: During the surgery ]
    Occurrence of the event (jaw thrust):yes or no and the number of episodes if yes

  4. Incidence of Respiratory events (mask-bag ventilation) [ Time Frame: During the surgery ]
    Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Christine El Yahchouchi, Instructor of Clinical Specialty, American University of Beirut Medical Center Identifier: NCT04123821     History of Changes
Other Study ID Numbers: BIO-2018-0549
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs