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Adenopathy; LocalizedNCT03815097

Prospective Study to Evaluate Mapleson Circuit With Monitored Anesthesia Care During Endobronchial Ultrasound (EBUS) Bronchoscopy

A study testing Mapleson circuit and nasal trumpet in people with Adenopathy; Localized and Lung Cancer, run by The Cooper Health System.

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

If the investigators can prove that the use of a mapleson circuit attached to a nasal trumpet employed during monitored anesthesia care leads to less sedation requirements, less procedure interruptions, shorter procedure duration, this would allow for to standardization of the type of anesthetic employed for EBUS at… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Adenopathy; Localized, Lung Cancer
What is being tested?
Mapleson circuit and nasal trumpet
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 Oct 2014to 30 Oct 2015
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

  • Age> 18
  • Patient undergoing EBUS bronchoscopy
  • Patient undergoing moderate conscious sedation

Who cannot join

  • Subjects age <18
  • Subjects requiring general anesthesia
  • 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

About this study

Official title: Prospective Study to Evaluate Mapleson Circuit With Monitored Anesthesia Care During EBUS Bronchoscopy

If the investigators can prove that the use of a mapleson circuit attached to a nasal trumpet employed during monitored anesthesia care leads to less sedation requirements, less procedure interruptions, shorter procedure duration, this would allow for to standardization of the type of anesthetic employed for EBUS at the investigators' institution and elsewhere. Less hypoxic episodes and less anesthetic requirements would benefit outcomes, lead to less recovery time and earlier discharges. Shorter procedural duration will create greater efficiency in the short procedure unit where the EBUS are performed.

Read the detailed description

Monitored anesthesia Care (MAC) is a type of conscious sedation delivered by an anesthesiologist, during which different 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 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 traditional MAC anesthesia, the patient is receiving oxygen via a nasal cannula or a mask capable of measuring capnography. If oxygen is delivered via a capnography mask, the routine is to create a hole with scissors in the side of the mask in order to allow the bronchoscope into the patient's mouth. The Mapleson Circuit is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag, an expiratory valve, tubing, and a connection to the patient. There are different types of Mapleson circuits depending on the different arrangements of its components. The investigators plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.

Endobronchial Ultrasound 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 conscious sedation 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 be very stimulating for this reason, which is the reason for the necessity for anesthesia. 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. The investigators have noticed that anesthesiologists who prefer to use the mapleson circuit with a nasal trumpet in place tend to less often interrupt the procedure due to hypoxia.

Placing a nasal trumpet in one nare allows access to the oropharynx, bypassing soft tissue that may relax under anesthesia and cause obstruction. Connecting that nasal trumpet to a device that can not only deliver oxygen efficiently when the subject is spontaneously breathing, but can also be used as an assist device to deliver assisted breaths in the event that the patient becomes hypoxic or apneic provides a method to oxygenate into the oropharynx without having to interrupt the procedure. It also helps maintain an airway from the nares into the oropharynx and prevent episodes of obstruction, which are commonly seen under MAC anesthesia. All anesthesiologists are familiar with the mapleson circuits as well as nasal trumpets.

No research has been done in this field specifically regarding 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 a mapleson circuit leads to less procedural interruptions, less hypoxic episodes and shorter procedural duration.

Being tested
Mapleson circuit and nasal trumpet
Medical subject headings
Lymphadenopathy, Lung Neoplasms

What participants receive

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

  • Mapleson circuit and nasal trumpetProcedure or surgery

    The Mapleson Circuit is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag, an expiratory valve, tubing, and a connection to the patient. There are different types of Mapleson circuits depending on the different arrangements of its components. We plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.

Study groups in NCT03815097
Study groupRoleWhat they receive
InterventionExperimentalMonitored anesthesia care with a mapleson circuit and nasal trumpet
Receives: Procedure: Mapleson circuit and nasal trumpet
Standard of careNo interventionStandard monitored anesthesia care

What is being measured

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

  1. Number of Interruptions of the procedures for any respiratory events

    An interruption is defined as any respiratory event that requires an intervention by the anesthesia provider or one requiring the procedural physician to temporarily stop the procedure.

    Measured: 2 years

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 2019
  2. Study start1 Oct 2014
  3. Primary completion30 Oct 2015
  4. Study completion30 Oct 2015

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
Non-randomised
Intervention model
Single group
Model description
This is a prospective, randomized study. The study will not be blinded. Subjects will be recruited from those who are referred to the interventional pulmonary department for EBUS bronchoscopy and who will be undergoing monitored anesthesia care (MAC) for their procedure. Subjects will then be randomized (via an computer randomizing algorithm) to receive conventional MAC vs. MAC with a mapleson circuit and nasal trumpet.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815097
Sponsor's protocol ID
CooperHS
Status last verified
Jan 2019
First submitted
22 Jan 2019
Last updated
24 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mapleson circuit and nasal trumpet in people with Adenopathy; Localized and Lung Cancer, run by The Cooper Health System.

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 3 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of Interruptions of the procedures for any respiratory events (time frame: 2 years). 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 24 Jan 2019.

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