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Clinical Trials/NCT05203328
NCT05203328RecruitingNot Applicable

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

The Cooper Health System1 site in 1 country198 target enrollmentStarted: February 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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

Experimental

High flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device

Intervention: Vapotherm (Device)

Regular nasal cannula

Active Comparator

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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