Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The Cooper Health System
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Number of interruption during EBUS procedure for hypoxia
Study Overview
Brief 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age>18 years
- •patient undergoing EBUS bronchoscopy with moderate conscious sedation.
Exclusion Criteria
- •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
Arms & Interventions
High flow nasal cannula oxygen
High flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device
Intervention: Vapotherm (Device)
Regular nasal cannula
Regular nasal cannula oxygen will be provided during the procedure
Intervention: Regular nasal canula (Device)
Outcomes
Primary Outcomes
Number of interruption during EBUS procedure for hypoxia
Time Frame: 1 day
We will count the number of interruptions during EBUS procedure for hypoxia
Secondary Outcomes
No secondary outcomes reported
