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Evaluation of Micropores SpiraLith Absorbents

Evaluation of Micropore's SpiraLith TM Absorbents Into Anesthesia Breathing Circuits

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02550470
Enrollment
186
Registered
2015-09-15
Start date
2015-07-31
Completion date
2016-10-31
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management During Operative Procedure

Brief 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.

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).

Interventions

DEVICECarbon Dioxide Absorbents

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.

DEVICEMicropore 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.

DRUGSevoflurane

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All comers to the 3 designated Operating Rooms.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Duration of Use Under Clinical Anesthesia of Each AbsorbentAssesed for the duration of each absorbent's use, up to 5 daysAverage lifespan of Spiralith® (minutes), Drägersorb® 800 Plus (minutes), Drägersorb® Free (minutes)

Secondary

MeasureTime frame
Cost of Each Absorbent's UseAssesed for the duration of each absorbent's use, up to 5 days

Countries

United States

Participant flow

Recruitment details

Patients were not actually enrolled. The randomly selected absorbent was loaded on the anesthesia workstation prior to the patient's arrival in the operating room.

Pre-assignment details

The number of participants is unknown as participants were not enrolled. The Enrollment number in the Protocol section is reporting the number of surgeries.

Participants by arm

ArmCount
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 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. Sevoflurane
0
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 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. Sevoflurane
58
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. Carbon Dioxide Absorbents: 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. Sevoflurane
0
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. Carbon Dioxide Absorbents: 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. Sevoflurane
65
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. Carbon Dioxide Absorbents: 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. Sevoflurane
0
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. Carbon Dioxide Absorbents: 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. Sevoflurane
63
Total186

Baseline characteristics

CharacteristicRandomized to Micropore SpiraLithRandomized to Drager 800 AbsorbentRandomized to Drager FreeTotal
Age, Categorical
<=18 years
NA Absorbent unitsNA Absorbent unitsNA Absorbent unitsNA Absorbent units
Age, Categorical
>=65 years
NA Absorbent unitsNA Absorbent unitsNA Absorbent unitsNA Absorbent units
Age, Categorical
Between 18 and 65 years
NA Absorbent unitsNA Absorbent unitsNA Absorbent unitsNA Absorbent units
Sex: Female, Male
Female
NA Absorbent unitsNA Absorbent unitsNA Absorbent unitsNA Absorbent units
Sex: Female, Male
Male
NA Absorbent unitsNA Absorbent unitsNA Absorbent unitsNA Absorbent units

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 580 / 650 / 63
other
Total, other adverse events
0 / 580 / 650 / 63
serious
Total, serious adverse events
0 / 580 / 650 / 63

Outcome results

Primary

Duration of Use Under Clinical Anesthesia of Each Absorbent

Average lifespan of Spiralith® (minutes), Drägersorb® 800 Plus (minutes), Drägersorb® Free (minutes)

Time frame: Assesed for the duration of each absorbent's use, up to 5 days

Population: Patients were not actually enrolled. Overall number of surgeries are provided

ArmMeasureValue (MEAN)Dispersion
Randomized to Micropore SpiraLithDuration of Use Under Clinical Anesthesia of Each Absorbent1931 minStandard Deviation 472
Randomized to Drager 800 AbsorbentDuration of Use Under Clinical Anesthesia of Each Absorbent1806 minStandard Deviation 343
Randomized to Drager FreeDuration of Use Under Clinical Anesthesia of Each Absorbent1527 minStandard Deviation 295
Secondary

Cost of Each Absorbent's Use

Time frame: Assesed for the duration of each absorbent's use, up to 5 days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026