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Completed

NCT Number: NCT04123821

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christian Rouphael

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of Respiratory events (desaturation)

    Time frame: During the procedure

    oxygen saturation (%)

  2. Incidence of Respiratory events (chin lift/jaw thrust)

    Time frame: During the procedure

    Occurrence of the event (chin lift/jaw thrust):yes or no and the number of episodes if yes

  3. Incidence of Respiratory events (mask-bag ventilation)

    Time frame: During the procedure

    Occurrence of the event (mask-bag ventilation):yes or no and the number of episodes if yes

Secondary outcomes

  1. Intubation

    Time frame: During the procedure

    Occurrence of the event (intubation): yes or no and the number of episodes if yes

  2. Interruptions during the case

    Time frame: During the procedure

    Occurrence of the event (Interruptions during the case): yes or no and the number of episodes if yes

  3. Incidence of hypotension

    Time frame: During the procedure

    Occurrence of the event (SBP<90 mmHg): yes or no and the number of episodes if yes

  4. Bradycardia

    Time frame: During the procedure

    Occurrence of the event (HR<50 beats/min): yes or no and the number of episodes if yes

  5. Epistaxis

    Time frame: During the procedure

    Development of epistaxis: yes or no and the number of episodes if yes

  6. Cough

    Time frame: During the procedure

    Development of cough: yes or no and the number of episodes if yes

  7. Laryngospasm

    Time frame: During the procedure

    Development of laryngospasm: yes or no and the number of episodes if yes

  8. Movement impeding procedure

    Time frame: During the procedure

    Patient's movement impeded the procedure :yes or no and the number of episodes if yes

  9. Satisfaction score of the anesthesiologist

    Time frame: Up to 2 hours after the procedure

    Satisfaction score of the anesthesiologist on a numerical rating scale from 0 to 10

  10. Satisfaction score of the proceduralist

    Time frame: Up to 2 hours after the procedure

    Satisfaction score of the proceduralist on a numerical rating scale from 0 to 10

  11. Satisfaction score of the patient

    Time frame: Up to 2 hours after the procedure

    Satisfaction score of the patient on a numerical rating scale from 0 to 10

Other outcomes

  1. Duration of the procedure

    Time frame: During the procedure

    Duration of the procedure in minutes

  2. Total amount of Propofol

    Time frame: During the procedure

    Total amount of Propofol in mg

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2019
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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