NCT02195245

Brief Summary

CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

July 11, 2014

Last Update Submit

October 12, 2016

Conditions

End Tidal CO2CO2 Removal

Keywords

CO2 filteranesthesiadevice

Outcome Measures

Primary Outcomes (1)

  • End tidal CO2 level

    After completion of the surgery, the digital respiration records are exported from the hospital database. End tidal CO2 is assessed as either in range \[4.1-5.6\]% or out of range \<4.1% or \>5.6%.

    Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.

Study Arms (2)

Control

NO INTERVENTION

Control - Observational (non interventional) data is collected from current state of the art absorber devices.

memsorb

EXPERIMENTAL

New CO2 filter - data is collected using the new CO2 absorber.

Device: memsorb

Interventions

memsorbDEVICE
memsorb

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk patient)
  • English-speaking patients
  • Scheduled for elective surgery
  • Length of anesthesia ≥ 60 minutes

You may not qualify if:

  • Pregnant
  • American Society of Anesthesiology Physical Status Class IV (high risk patient)
  • Patients schedule for emergency surgery
  • Known respiratory disease, including COPD and severe asthma
  • Have elevated pressure in your brain (intra cranial pressure, ICP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth II HSC, Halifax Infirmary Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 21, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

CA(1)