Trial Outcomes & Findings for Evaluation of Micropore"s SpiraLith Absorbents (NCT NCT02550470)

NCT ID: NCT02550470

Last Updated: 2022-04-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 186 participants
• Primary outcome timeframe: Assesed for the duration of each absorbent's use, up to 5 days
• Results posted on: 2022-04-08

Participant Flow

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.

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

Unit of analysis: Absorbent units

Participant milestones

Measure	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	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	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
Overall Study STARTED	0 58	0 65	0 63
Overall Study COMPLETED	0 58	0 65	0 63
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Micropore"s SpiraLith Absorbents

Baseline characteristics by cohort

Measure	Randomized to Micropore SpiraLith n=58 Absorbent units 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	Randomized to Drager 800 Absorbent n=65 Absorbent units 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	Randomized to Drager Free n=63 Absorbent units 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	Total n=186 Absorbent units Total of all reporting groups
Age, Categorical <=18 years	NA Absorbent units n=58 Absorbent units	NA Absorbent units n=65 Absorbent units	NA Absorbent units n=63 Absorbent units	NA Absorbent units n=186 Absorbent units
Age, Categorical Between 18 and 65 years	NA Absorbent units n=58 Absorbent units	NA Absorbent units n=65 Absorbent units	NA Absorbent units n=63 Absorbent units	NA Absorbent units n=186 Absorbent units
Age, Categorical >=65 years	NA Absorbent units n=58 Absorbent units	NA Absorbent units n=65 Absorbent units	NA Absorbent units n=63 Absorbent units	NA Absorbent units n=186 Absorbent units
Sex: Female, Male Female	NA Absorbent units n=58 Absorbent units	NA Absorbent units n=65 Absorbent units	NA Absorbent units n=63 Absorbent units	NA Absorbent units n=186 Absorbent units
Sex: Female, Male Male	NA Absorbent units n=58 Absorbent units	NA Absorbent units n=65 Absorbent units	NA Absorbent units n=63 Absorbent units	NA Absorbent units n=186 Absorbent units

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	Randomized to Micropore SpiraLith n=58 Absorbent units 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	Randomized to Drager 800 Absorbent n=65 Absorbent units 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	Randomized to Drager Free n=63 Absorbent units 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
Duration of Use Under Clinical Anesthesia of Each Absorbent	1931 min Standard Deviation 472	1806 min Standard Deviation 343	1527 min Standard Deviation 295

SECONDARY outcome

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

Outcome measures

Outcome data not reported

Adverse Events

Randomized to Micropore SpiraLith

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized to Drager 800 Absorbent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized to Drager Free

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eloy, PI

Rutgers - New Jersey Medical School

Phone: 973 972 5007

Email: eloyje@njms.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place