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Monitored Anesthesia CareNCT04123821

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

A study testing Nasopharyngeal airway in people with Monitored Anesthesia Care and Gastrointestinal Endoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Nasopharyngeal airway
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteLebanon
Study dates
11 Nov 2019to 8 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • Christian Rouphael

    Beirut

Other trials in Lebanon

About this study

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

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.

Read the 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.

Being tested
Nasopharyngeal airway

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasopharyngeal airwayDevice

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

Study groups in NCT04123821
Study groupRoleWhat they receive
Group AExperimentalNasopharyngeal airway with 5L/min oxygen through nasal cannula
Receives: Device: Nasopharyngeal airway
Group BNo intervention5 L/min oxygen through nasal cannula alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Respiratory events (desaturation)

    oxygen saturation (%)

    Measured: During the procedure

  2. 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

    Measured: During the procedure

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

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

    Measured: During the procedure

Secondary outcomes (11)

  1. Intubation

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

    Measured: During the procedure

  2. Interruptions during the case

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

    Measured: During the procedure

  3. Incidence of hypotension

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

    Measured: During the procedure

  4. Bradycardia

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

    Measured: During the procedure

  5. Epistaxis

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

    Measured: During the procedure

  6. Cough

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

    Measured: During the procedure

  7. Laryngospasm

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

    Measured: During the procedure

  8. Movement impeding procedure

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

    Measured: During the procedure

  9. Satisfaction score of the anesthesiologist

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

    Measured: Up to 2 hours after the procedure

  10. Satisfaction score of the proceduralist

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

    Measured: Up to 2 hours after the procedure

  11. Satisfaction score of the patient

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

    Measured: Up to 2 hours after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2019
  2. Study start11 Nov 2019
  3. Primary completion8 Nov 2023
  4. Study completion8 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123821
Sponsor's protocol ID
BIO-2018-0549
Status last verified
Feb 2025
First submitted
8 Oct 2019
Last updated
11 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasopharyngeal airway in people with Monitored Anesthesia Care and Gastrointestinal Endoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Respiratory events (desaturation) (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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