Hypothermia; AnesthesiaNCT00980642
Accuracy of the Drager Dual-sensor Temperature Measurement System
A study testing Draeger double-sensor, Esophageal stethoscope temperature sensor and Foley catheter temperature sensor in people with Hypothermia; Anesthesia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- Draeger double-sensor, Esophageal stethoscope temperature sensor and Foley catheter temperature sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing trauma surgery with general anesthesia
- Patients undergoing orthopedic surgery with regional anesthesia
Who cannot join
- Younger than 18 or older than 80 years of age
- Have a pre-existing nasogastric tube
- Require bispectral index monitoring
- Upper esophageal disease
- Forehead rash or infection
- Oral infection or trauma
- Ear infection or drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.
Read the detailed description
We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- Draeger double-sensor, Esophageal stethoscope temperature sensor, Foley catheter temperature sensor
- Keywords
- surgery, thermometer, non-invasive, interoperative core temperature, anesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Draeger double-sensorDevice
The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.
Esophageal stethoscope temperature sensorDevice
Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.
Foley catheter temperature sensorDevice
Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Other | Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. Receives: Device: Draeger double-sensor; Device: Esophageal stethoscope temperature sensor |
| Regional anesthesia | Other | Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. Receives: Device: Draeger double-sensor; Device: Foley catheter temperature sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.
Measured: From anesthesia induction to the end of surgery
Secondary outcomes (2)
Sensitivity for Detection of Hypothermia
Hypothermia is defined as a temperature < 36 Celsius degree
Measured: From anesthesia induction to the end of surgery
Specificity for Detection of Hypothermia
Hypothermia will be defined as a temperature < 36 Celsius degree
Measured: From anesthesia induction to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Kurz, The Cleveland Clinic
- Investigators
- Andrea Kurz, M.D., Principal investigator, The Cleveland ClinicDaniel I Sessler, M.D., Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980642
- Sponsor's protocol ID
- 08-453
- Status last verified
- May 2017
- First submitted
- 18 Sep 2009
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
- ClinicalTrials.gov ID
- NCT00980642
- Acronym / sponsor ID
- 08-453
- Conditions
- Hypothermia; Anesthesia
- Keywords
- surgery, thermometer, non-invasive, interoperative core temperature, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.
Detailed description
We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Other | Device: Draeger double-sensor, Device: Esophageal stethoscope temperature sensorTemperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. |
| Regional anesthesia | Other | Device: Draeger double-sensor, Device: Foley catheter temperature sensorTemperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing trauma surgery with general anesthesia
- Patients undergoing orthopedic surgery with regional anesthesia
Key exclusion criteria (7 listed)
- Younger than 18 or older than 80 years of age
- Have a pre-existing nasogastric tube
- Require bispectral index monitoring
- Upper esophageal disease
- Forehead rash or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Draeger double-sensorThe sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin. | Device | General anesthesia, Regional anesthesia |
| Esophageal stethoscope temperature sensorEsophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery. | Device | General anesthesia |
| Foley catheter temperature sensorUrinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery | Device | Regional anesthesia |
Primary outcome
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
Time frame: From anesthesia induction to the end of surgery
Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.
2 secondary outcomes
Sensitivity for Detection of Hypothermia
Time frame: From anesthesia induction to the end of surgery
Specificity for Detection of Hypothermia
Time frame: From anesthesia induction to the end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypothermia; Anesthesia
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Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
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Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
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Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Shivering, Post-Spinal Shivering
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kurz, M.D. principal investigator
The Cleveland Clinic
Daniel I Sessler, M.D. study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Draeger double-sensor, Esophageal stethoscope temperature sensor and Foley catheter temperature sensor in people with Hypothermia; Anesthesia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature (time frame: From anesthesia induction to the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.