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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| High flow nasal cannula oxygen | Experimental | High flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device Receives: Device: Vapotherm |
| Regular nasal cannula | Active comparator | Regular 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.
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.
- First posted24 Jan 2022
- Study start1 Feb 2022
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT05203328
- Acronym / sponsor ID
- 21-095
- Conditions
- Lung Cancer
- Keywords
- EBUS, bronchoscopy, Vapotherm, high-flow nasal cannula, monitored anesthesia care (MAC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula oxygen | Experimental | Device: VapothermHigh flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device |
| Regular nasal cannula | Active comparator | Device: Regular nasal canulaRegular nasal cannula oxygen will be provided during the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age>18 years
- patient undergoing EBUS bronchoscopy with moderate conscious sedation.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VapothermAlso: High flow nasal cannulaMonitored anesthesia care with oxygen supplementation through a high-flow nasal cannula | Device | High flow nasal cannula oxygen |
| Regular nasal canulaMonitored anesthesia care with oxygen supplementation through a regular nasal cannula | Device | Regular nasal cannula |
Primary outcome
Number of interruption during EBUS procedure for hypoxia
Time frame: 1 day
We will count the number of interruptions during EBUS procedure for hypoxia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.