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Lung CancerNCT05203328

Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy

A study testing Vapotherm and Regular nasal canula in people with Lung Cancer, run by The Cooper Health System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Our objective is to assess whether the use of high flow nasal cannula (Vapotherm, Exeter, NH) with monitored anesthesia care (MAC) during an endobronchial ultrasound (EBUS) bronchoscopy procedure will lead to less procedure interruptions, less hypoxic episodes, shorter duration of hypoxic episodes and shorter… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Vapotherm and Regular nasal canula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteUnited States
Study dates
1 Feb 2022to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age>18 years
  • patient undergoing EBUS bronchoscopy with moderate conscious sedation.

Who cannot join

  • subjects with previous nasal surgeries
  • subjects with oxygen saturation <90% on room air prior to procedure
  • subjects who are pregnant
  • subjects with known facial fractures or recent facial trauma
  • subjects on any anticoagulation that cannot be discontinued prior to the procedure

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Cooper University Hospital

    Camden, New Jersey, 08103

    Wissam Abouzgheib, MD, 800-826-6737, abouzgheib-wissam@cooperhealth.edu

    Christopher Ambrogi, DO, ambrogi-christopher@cooperhealth.edu

    Recruiting

Other trials in United States

About this study

Official title: Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care

Our objective is to assess whether the use of high flow nasal cannula (Vapotherm, Exeter, NH) with monitored anesthesia care (MAC) during an endobronchial ultrasound (EBUS) bronchoscopy procedure will lead to less procedure interruptions, less hypoxic episodes, shorter duration of hypoxic episodes and shorter procedural durations when compared to regular MAC using a regular nasal canula.

Read the detailed description

Background:

MAC is a type of conscious sedation delivered by an anesthesiologist, during which different sedative medications are given, usually via the intravenous route, to obtain varying levels of sedation depending on the surgery or procedure. This is routinely done for all EBUS procedures at Cooper University Hospital. Since a MAC anesthesia does not include having a secure airway, occasionally the patient may develop episodes in which their oxygen level drops. During these episodes, the anesthesiologist will stop the procedure temporarily until the oxygen level returns to a normal range.

Often, changes in sedation amount is also required during this time. In a traditional MAC, the patient receives oxygen via a nasal cannula or a capnomask. If oxygen is delivered via a capnomask, the routine is to create a hole with scissors in the side of the capnomask in order to allow the bronchoscope into the patient's mouth. The Vapotherm is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. The Vapotherm is a high flow nasal cannula that works by constantly providing humidified and heated high flow oxygen thereby creating positive end expiratory pressure that is useful for alveolar recruitment. It looks similar to nasal cannula but a little thicker and is also placed in the nostrils.

EBUS is a technique that uses ultrasound along with bronchoscopy to visualize the airway wall and structures adjacent to it. The clinical application and diagnostic benefits of EBUS have been well established, including diagnosis and staging of lung cancer. EBUS is usually performed under MAC for patient comfort.

The route of entry for the EBUS scope requires passage through the vocal cords and into the airways. The procedure tends to cause some discomfort and generally needs anesthesia to make people comfortable. Due to the amount of anesthesia required to subdue the airway reflexes for a smooth procedure, occasionally, the patient may become apneic or obstruct and not take adequate tidal volume breaths, leading to hypoxia. During these instances, the procedure is halted until the patient's oxygen levels return to baseline. We have noticed that anesthesiologists who prefer to use the Vapotherm in place tend to less often interrupt the procedure due to hypoxia.

Vapotherm high flow nasal cannula therapy is similar in efficacy to transtracheal catheters, which are intended to attenuate the effects of anatomical dead space on breathing efficiency. The mechanisms include washout of nasopharyngeal dead space, reduction of inspiratory resistance in the nasopharynx, improvement in airway and lung mechanics thereby providing methods to oxygenate without having to interrupt the procedure. All anesthesiologists at Cooper University Hospital are familiar with the Vapotherm high flow nasal cannula.

No research has been done in this field specifically regarding to EBUS. There is no anesthetic standard of care that is specific for an EBUS procedure. The anesthesia can be local anesthesia alone, with just topicalization of the airways, or MAC, or even general anesthesia with an endotracheal tube or a laryngeal mask airway. The choice is practitioner dependent.

Our experience has been that MAC with Vapotherm high flow leads to less procedural interruptions, less hypoxic episodes and shorter procedural durations.

Hypotheses:

Our hypothesis is that the use of the Vapotherm high flow nasal cannula with monitored anesthesia care (MAC) is associated with less procedure interruptions, less hypoxic episodes and shorter procedural durations.

Significance of the research:

If we can prove that the use of a Vapotherm high flow employed during MAC care leads to less procedure interruptions and shorter procedure durations, this would allow us to standardize the type of oxygen supply employed for EBUS in our institution and elsewhere. Less hypoxic episodes would benefit outcomes, lead to less recovery time and earlier discharges. Shorter procedural durations will create greater efficiency in the short procedure unit where the EBUS procedures are performed.

Conditions
Lung Cancer
Being tested
Vapotherm, Regular nasal canula
Keywords
EBUS, bronchoscopy, Vapotherm, high-flow nasal cannula, monitored anesthesia care (MAC)
Medical subject headings
Lung Neoplasms

What participants receive

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

  • VapothermDevice

    Also called High flow nasal cannula

    Monitored anesthesia care with oxygen supplementation through a high-flow nasal cannula

  • Regular nasal canulaDevice

    Monitored anesthesia care with oxygen supplementation through a regular nasal cannula

Study groups in NCT05203328
Study groupRoleWhat they receive
High flow nasal cannula oxygenExperimentalHigh flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device
Receives: Device: Vapotherm
Regular nasal cannulaActive comparatorRegular nasal cannula oxygen will be provided during the procedure
Receives: Device: Regular nasal canula

What is being measured

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

  1. Number of interruption during EBUS procedure for hypoxia

    We will count the number of interruptions during EBUS procedure for hypoxia

    Measured: 1 day

Timeline

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

  1. First posted24 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completionMar 2026 (estimated)
  4. Study completionMay 2026 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203328
Sponsor's protocol ID
21-095
Status last verified
Sep 2025
First submitted
29 Nov 2021
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vapotherm and Regular nasal canula in people with Lung Cancer, run by The Cooper Health System at 1 site in United States.

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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Sep 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Wissam Abouzgheib, MD ((800) 826-6737, Abouzgheib-Wissam@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of interruption during EBUS procedure for hypoxia (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Sep 2025.

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