Body Temperature During SurgeryTTPNCT01489280
Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System
An observational study of Body Temperature During Surgery, run by Medisim Ltd at 2 sites in Israel.
Trial summary
In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Temperature During Surgery
- How many people
- 800 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ages 0 and up, patients subjected to elective surgery.
Who may be able to join
- The patients will be chosen for the trial if the following criteria are met:
- Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.
- The surgical procedure requires temperature monitoring.
- Informed consent signed by the patient or his legal guardian.
Who cannot join
- The patients will be excluded from the trial if one of the following occurs:
- The medical staff decides that the patient should not participate.
- Unavailable measurement site in case of operations performed in the head area.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Rambam medical center
Haifa
Avraham Weissman, 97248542381
- Recruiting
Wolfson Medical Center
Holon
Shmuel Evron, Prof., 97235028152
About this study
Official title: Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.
The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.
- Conditions
- Body Temperature During Surgery
- Keywords
- Temple Touch Pro, Medisim, temperature, surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature During SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489280
- Sponsor's protocol ID
- 26-115-630
- Acronym
- TTP
- Status last verified
- Sep 2012
- First submitted
- 7 Dec 2011
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
- ClinicalTrials.gov ID
- NCT01489280
- Acronym / sponsor ID
- TTP / 26-115-630
- Conditions
- Body Temperature During Surgery
- Keywords
- Temple Touch Pro, Medisim, temperature, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Medisim LtdIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2014 (estimated)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.
The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ages 0 and up, patients subjected to elective surgery.
Key inclusion criteria (4 listed)
- Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.
- The surgical procedure requires temperature monitoring.
- Informed consent signed by the patient or his legal guardian.
Key exclusion criteria (3 listed)
- The medical staff decides that the patient should not participate.
- Unavailable measurement site in case of operations performed in the head area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
Related trials for Body Temperature During Surgery
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Active, not recruitingObservational study
Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
Cardiopulmonary Bypass, Hypothermia; Anesthesia
Not yet recruiting
Neuroprotective Effect of Mild Hypothermia Versus Normothermia During Cardiopulmonary Bypass of Coronary Artery Surgery
Coronary Artery Disease, Brain Injury
Recruiting
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Ischemic Heart Disease, Valvular Heart Disease
Enrolling by invitationObservational study
Constructing a Risk Prediction Model for Intraoperative Hypothermia in Children Under General Anesthesia
Hypothermia, Accidental, Hypothermia; Anesthesia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature During Surgery, run by Medisim Ltd at 2 sites in Israel.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 11 Sep 2012.