Airway Management During Operative ProcedureNCT02550470
Evaluation of Micropore"s SpiraLith Absorbents
An observational study of Airway Management During Operative Procedure, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This is an observational study investigating the duration of use and cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+, Drägersorb® Free. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Management During Operative Procedure
- What is being tested?
- Carbon Dioxide Absorbents, Micropore SpiraLith and Sevoflurane
- Type of treatment
- Medical device
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients scheduled for surgery in the selected OR Rooms
Who may be able to join
- All comers to the 3 designated Operating Rooms.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Micropore's SpiraLith TM Absorbents Into Anesthesia Breathing Circuits
This is an observational study investigating the duration of use and cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+, Drägersorb® Free.
Read the detailed description
The Principal Investigator will obtain IRB approval under expedited review. No patient written informed consent will be required as this is a process improvement minimal risk study that does not necessitates use of patient Protected Health Information. Participants will not be actually enrolled. There will be no change to the standard of care resulting from data collection on CO2 absorbent use, and no patient identifiers will be exposed. The study will take place in three operating rooms, three rooms equipped with Drager Appollo® anesthesia workstations (Draeger Medical Inc., USA) requiring use of CLIC style absorbents. An unblinded member of the research team will have access to the randomization schedule and will be responsible to place Drägersorb® 800+, Drägersorb® Free, or Micropore SpiralithTM absorbents in the designated operating rooms with three Appollo® (CLIC style absorbent). The randomly selected absorbent will be loaded on the anesthesia workstation prior to the patient's arrival in the operating room and the date, time and randomization coding will be marked on the cassette as it appears on the randomization schedule. The anesthesia providers will use low flow anesthesia with or without Sevoflurane in the 3 selected operating rooms. The practice at this institution is to use a semi-closed breathing circuit and maintain a fresh gas flow rate of approximately 2L/min with a selected tidal volume of 6-8 mL/Kg during the maintenance phase of the procedure. Flow rate would be approximately 10 L/min during the induction of anesthesia. The investigators will document time that is required to achieve 90% of the sevoflurane target concentration. These guidelines will be clearly indicated on the anesthesia workstation to ensure consistency across the multiple providers. Data logger files will be saved at the end of each case using the same coding label as the marked cassette. When the absorbent is replaced, the date and time of removal should be clearly marked on the cassette. This same date and time information should also be recorded on the source document ensuring that operating room numbers and anesthesia workstations are clearly and accurately recorded. In order to maintain the anesthesia provider blinded to the type of absorbent used, a white sheet of paper will be taped around the outside of the cassette compartment. The time that the patient is connected and disconnected from the breathing circuit must be recorded on the source document. In addition the investigators will document The absorbent unit will be replaced when the inspiratory CO2 concentration (obtained from the inspiratory limb of the breathing circuit) reaches 4 mmHg. This is an acceptable maximal inspiratory CO2 concentration which leaves sufficient time to complete a case, thereby avoiding cassette replacement during anesthesia. The anesthesia workstation fresh gas flows will be turned off at the time that the patient is disconnected from the breathing circuit to avoid variability in absorbent water content.
The absorbing capacity of the cassettes will be determined by calculating the duration of absorbent use from the time of first use to the time of cassette removal. Each absorbent will be evaluated through a total of 5 rounds. We expect to have about 60 surgeries for each absorbent. Averaged duration of absorbent use will be compared between different types of absorbents (Drägersorb® 800+, Drägersorb® Free, Micropore SpiralithTM).
- Being tested
- Carbon Dioxide Absorbents, Micropore SpiraLith, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Dioxide AbsorbentsDevice
Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases.
Micropore SpiraLithDevice
lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.
SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Randomized to Micropore SpiraLith | lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8 Receives: Device: Micropore SpiraLith; Drug: Sevoflurane | |
| Randomized to Drager 800 Absorbent | Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases. Receives: Device: Carbon Dioxide Absorbents; Drug: Sevoflurane | |
| Randomized to Drager Free | Calcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases. Receives: Device: Carbon Dioxide Absorbents; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Use Under Clinical Anesthesia of Each Absorbent
Average lifespan of Spiralith® (minutes), Drägersorb® 800 Plus (minutes), Drägersorb® Free (minutes)
Measured: Assesed for the duration of each absorbent's use, up to 5 days
Secondary outcomes (1)
Cost of Each Absorbent's Use
Measured: Assesed for the duration of each absorbent's use, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Airway Management During Operative ProcedureStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Daniel Eloy, MD, Rutgers, The State University of New Jersey
- Investigators
- J.Daniel Eloy, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550470
- Sponsor's protocol ID
- PRO20140001012
- Status last verified
- Feb 2022
- First submitted
- 3 Sep 2015
- Last updated
- 8 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Micropore's SpiraLith TM Absorbents Into Anesthesia Breathing Circuits
- ClinicalTrials.gov ID
- NCT02550470
- Acronym / sponsor ID
- PRO20140001012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 8 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study investigating the duration of use and cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+, Drägersorb® Free.
Detailed description
The Principal Investigator will obtain IRB approval under expedited review. No patient written informed consent will be required as this is a process improvement minimal risk study that does not necessitates use of patient Protected Health Information. Participants will not be actually enrolled. There will be no change to the standard of care resulting from data collection on CO2 absorbent use, and no patient identifiers will be exposed. The study will take place in three operating rooms, three rooms equipped with Drager Appollo® anesthesia workstations (Draeger Medical Inc., USA) requiring use of CLIC style absorbents. An unblinded member of the research team will have access to the randomization schedule and will be responsible to place Drägersorb® 800+, Drägersorb® Free, or Micropore SpiralithTM absorbents in the designated operating rooms with three Appollo® (CLIC style absorbent). The randomly selected absorbent will be loaded on the anesthesia workstation prior to the patient's arrival in the operating room and the date, time and randomization coding will be marked on the cassette as it appears on the randomization schedule. The anesthesia providers will use low flow anesthesia with or without Sevoflurane in the 3 selected operating rooms. The practice at this institution is to use a semi-closed breathing circuit and maintain a fresh gas flow rate of approximately 2L/min with a selected tidal volume of 6-8 mL/Kg during the maintenance phase of the procedure. Flow rate would be approximately 10 L/min during the induction of anesthesia. The investigators will document time that is required to achieve 90% of the sevoflurane target concentration. These guidelines will be clearly indicated on the anesthesia workstation to ensure consistency across the multiple providers. Data logger files will be saved at the end of each case using the same coding label as the marked cassette. When the absorbent is replaced, the date and time of removal should be clearly marked on the cassette. This same date and time information should also be recorded on the source document ensuring that operating room numbers and anesthesia workstations are clearly and accurately recorded. In order to maintain the anesthesia provider blinded to the type of absorbent used, a white sheet of paper will be taped around the outside of the cassette compartment. The time that the patient is connected and disconnected from the breathing circuit must be recorded on the source document. In addition the investigators will document The absorbent unit will be replaced when the inspiratory CO2 concentration (obtained from the inspiratory limb of the breathing circuit) reaches 4 mmHg. This is an acceptable maximal inspiratory CO2 concentration which leaves sufficient time to complete a case, thereby avoiding cassette replacement during anesthesia. The anesthesia workstation fresh gas flows will be turned off at the time that the patient is disconnected from the breathing circuit to avoid variability in absorbent water content.
The absorbing capacity of the cassettes will be determined by calculating the duration of absorbent use from the time of first use to the time of cassette removal. Each absorbent will be evaluated through a total of 5 rounds. We expect to have about 60 surgeries for each absorbent. Averaged duration of absorbent use will be compared between different types of absorbents (Drägersorb® 800+, Drägersorb® Free, Micropore SpiralithTM).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized to Micropore SpiraLith | – | Device: Micropore SpiraLith, Drug: Sevofluranelithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8 |
| Randomized to Drager 800 Absorbent | – | Device: Carbon Dioxide Absorbents, Drug: SevofluraneCalcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases. |
| Randomized to Drager Free | – | Device: Carbon Dioxide Absorbents, Drug: SevofluraneCalcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients scheduled for surgery in the selected OR Rooms
Key inclusion criteria (1 listed)
- All comers to the 3 designated Operating Rooms.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Carbon Dioxide AbsorbentsCalcium hydroxide lime is one of the newer clinically available carbon dioxide absorbents and probably considered the current standard of care. It is mainly composed of calcium hydroxide and calcium chloride and contains two setting agents: calcium sulfate and polyvinylpyrrolidine which contribute to the increased hardness and porosity of this absorbent. The most significant advantage of calcium hydroxide lime over other agents is that it is produced without sodium and potassium hydroxide which are strong bases. | Device | Randomized to Drager 800 Absorbent, Randomized to Drager Free |
| Micropore SpiraLithlithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability. | Device | Randomized to Micropore SpiraLith |
| Sevoflurane | Drug | Randomized to Drager 800 Absorbent, Randomized to Drager Free, Randomized to Micropore SpiraLith |
Primary outcome
Duration of Use Under Clinical Anesthesia of Each Absorbent
Time frame: Assesed for the duration of each absorbent's use, up to 5 days
Average lifespan of Spiralith® (minutes), Drägersorb® 800 Plus (minutes), Drägersorb® Free (minutes)
1 secondary outcome
Cost of Each Absorbent's Use
Time frame: Assesed for the duration of each absorbent's use, up to 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
J.Daniel Eloy, MD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management During Operative Procedure, run by Rutgers, The State University of New Jersey 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 1 inclusion and 1 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 8 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Use Under Clinical Anesthesia of Each Absorbent (time frame: Assesed for the duration of each absorbent's use, up to 5 days). 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 8 Apr 2022.