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.
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.
- Conditions
- Adenopathy; Localized, Lung Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Monitored anesthesia care with a mapleson circuit and nasal trumpet Receives: Procedure: Mapleson circuit and nasal trumpet |
| Standard of care | No intervention | Standard monitored anesthesia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted24 Jan 2019
- Study start1 Oct 2014
- Primary completion30 Oct 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenopathy; LocalizedStudies 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
- 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)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Mapleson Circuit With Monitored Anesthesia Care During EBUS Bronchoscopy
- ClinicalTrials.gov ID
- NCT03815097
- Acronym / sponsor ID
- CooperHS
- Conditions
- Adenopathy; Localized, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 24 Jan 2019 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Mapleson circuit and nasal trumpetMonitored anesthesia care with a mapleson circuit and nasal trumpet |
| Standard of care | No intervention | –Standard monitored anesthesia care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18
- Patient undergoing EBUS bronchoscopy
- Patient undergoing moderate conscious sedation
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Mapleson circuit and nasal trumpetThe 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. | Procedure or surgery | Intervention |
Primary outcome
Number of Interruptions of the procedures for any respiratory events
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.