Evaluation of Micropore"s SpiraLith Absorbents

NCT02550470 | Completed Results

• 1 other identifier: PRO20140001012
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management During Operative Procedure

Outcome Measures

Primary Outcomes (1)

• Duration of Use Under Clinical Anesthesia of Each Absorbent

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

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

Secondary Outcomes (1)

• Cost of Each Absorbent's Use

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

Study Arms (3)

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

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.

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.

Device: Carbon Dioxide Absorbents; Drug: Sevoflurane

Interventions

Carbon Dioxide Absorbents DEVICE

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.

Randomized to Drager 800 Absorbent; Randomized to Drager Free

Micropore SpiraLith DEVICE

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.

Randomized to Micropore SpiraLith

Sevoflurane DRUG

Randomized to Drager 800 Absorbent; Randomized to Drager Free; Randomized to Micropore SpiraLith

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for surgery in the selected OR Rooms

You may qualify if:

• All comers to the 3 designated Operating Rooms.

You may not qualify if:

• None

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Dr. Eloy, PI
• Organization: Rutgers - New Jersey Medical School

eloyje@njms.rutgers.edu

973 972 5007

Study Officials

• J.Daniel Eloy, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthsiology, NJMS

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 15, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-02

Locations

US (1)