Airway Management During Operative Procedure
Conditions
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
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* All comers to the 3 designated Operating Rooms.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Use Under Clinical Anesthesia of Each Absorbent | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Cost of Each Absorbent's Use | Assesed 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
| Arm | Count |
|---|---|
| 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 |
| Total | 186 |
Baseline characteristics
| Characteristic | Randomized to Micropore SpiraLith | Randomized to Drager 800 Absorbent | Randomized to Drager Free | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | NA Absorbent units | NA Absorbent units | NA Absorbent units | NA Absorbent units |
| Age, Categorical >=65 years | NA Absorbent units | NA Absorbent units | NA Absorbent units | NA Absorbent units |
| Age, Categorical Between 18 and 65 years | NA Absorbent units | NA Absorbent units | NA Absorbent units | NA Absorbent units |
| Sex: Female, Male Female | NA Absorbent units | NA Absorbent units | NA Absorbent units | NA Absorbent units |
| Sex: Female, Male Male | NA Absorbent units | NA Absorbent units | NA Absorbent units | NA Absorbent units |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 65 | 0 / 63 |
| other Total, other adverse events | 0 / 58 | 0 / 65 | 0 / 63 |
| serious Total, serious adverse events | 0 / 58 | 0 / 65 | 0 / 63 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized to Micropore SpiraLith | Duration of Use Under Clinical Anesthesia of Each Absorbent | 1931 min | Standard Deviation 472 |
| Randomized to Drager 800 Absorbent | Duration of Use Under Clinical Anesthesia of Each Absorbent | 1806 min | Standard Deviation 343 |
| Randomized to Drager Free | Duration of Use Under Clinical Anesthesia of Each Absorbent | 1527 min | Standard Deviation 295 |
Cost of Each Absorbent's Use
Time frame: Assesed for the duration of each absorbent's use, up to 5 days