SurgeryNCT00614588
Temperature Measurement in Post-Anesthesia Care Units
An observational study of Surgery and Postoperative, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Postoperative, Laparoscopic Surgery
- What is being tested?
- Body temperature thermometers
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.
Who may be able to join
- 18 to 80 years of age
- American Society of Anesthesiologists (ASA) physical status of 1-3
- laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery
Who cannot join
- under 18 or over 80 years of age
- pre-existing nasogastric tube
- require bispectral index monitoring
- upper esophageal disease
- forehead rash or infection, oral infection or trauma, or ear infection or drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Temperature Measurement in Post-Anesthesia Care Units
This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.
Read the detailed description
Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:
- esophagus using an internal stethoscope
- urinary bladder using a catheter
- ear canal
- skin of the forehead using adhesive devices(4 thermometers)
- axilla ("armpit") using adhesive devices(2 thermometers)
- mouth
- skin of the upper chest
- Conditions
- Surgery, Postoperative, Laparoscopic Surgery, General Anesthesia
- Being tested
- Body temperature thermometers
- Keywords
- temperature, monitor, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body temperature thermometersDevice
Also called 1. Distal esophagus (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,, 2. Bladder (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,, 3. Infrared-aural canal bilaterally (GENIUS Model 3000A, Kendall Healthcare), 4. Temporal artery with an electronic scanning thermometer (Model TAT-5000, Exergen)
Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.
| Study group | Role | What they receive |
|---|---|---|
| observation group | Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter. Receives: Device: Body temperature thermometers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.
Measured: Discharge from Post Anesthesia Care Unit
Secondary outcomes (1)
To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.
Measured: PostAnesthesia Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland ClinicDaniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614588
- Sponsor's protocol ID
- 07-986
- Status last verified
- Jul 2016
- First submitted
- 31 Jan 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Temperature Measurement in Post-Anesthesia Care Units
- ClinicalTrials.gov ID
- NCT00614588
- Acronym / sponsor ID
- 07-986
- Conditions
- Surgery, Postoperative, Laparoscopic Surgery, General Anesthesia
- Keywords
- temperature, monitor, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Feb 2008 (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.
This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.
Detailed description
Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:
- esophagus using an internal stethoscope
- urinary bladder using a catheter
- ear canal
- skin of the forehead using adhesive devices(4 thermometers)
- axilla ("armpit") using adhesive devices(2 thermometers)
- mouth
- skin of the upper chest
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Device: Body temperature thermometersPatients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.
Key inclusion criteria (3 listed)
- 18 to 80 years of age
- American Society of Anesthesiologists (ASA) physical status of 1-3
- laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery
Key exclusion criteria (5 listed)
- under 18 or over 80 years of age
- pre-existing nasogastric tube
- require bispectral index monitoring
- upper esophageal disease
- forehead rash or infection, oral infection or trauma, or ear infection or drainage
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 |
|---|---|---|
| Body temperature thermometersAlso: 1. Distal esophagus (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,, 2. Bladder (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,, 3. Infrared-aural canal bilaterally (GENIUS Model 3000A, Kendall Healthcare), 4. Temporal artery with an electronic scanning thermometer (Model TAT-5000, Exergen)Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer. | Device | observation group |
Primary outcome
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.
Time frame: Discharge from Post Anesthesia Care Unit
1 secondary outcome
To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.
Time frame: PostAnesthesia Care Unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
Related trials for Surgery
Active, not recruiting
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Brain Tumor
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma, Sinonasal Carcinoma
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
Daniel I Sessler, MD study chair
The Cleveland Clinic
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Postoperative, 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 3 inclusion and 5 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 20 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use. (time frame: Discharge from Post Anesthesia Care Unit). 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 20 Jul 2016.