Major Surgery Under General AnesthesiaNCT02756910
Perioperative Accuracy of the Raiing Wireless Axillary Thermometer
An observational study of Major Surgery Under General Anesthesia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A new wireless axillary thermometer from Raiing Medical uses a proprietary system, iThermonitor (WT701), to provide better estimates of core temperature than a conventional axillary probe. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Surgery Under General Anesthesia
- What is being tested?
- iThermonitor (WT701)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Sep 2016
- Phase
- Observational
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: Adult surgery patients
Who may be able to join
- adults having an American Society of Anesthesiologists (ASA) physical status of 1-3
- must be scheduled for surgery of the abdomen or pelvis that is expected to last 1.5-4 hours
- require general endotracheal anesthesia and insertion of a Foley catheter
Who cannot join
- patients in whom neither esophageal nor nasopharyngeal temperature monitoring is practical
- patients in whom active intravenous infusion is required in both arms
- patients who are allergic to hydrogel
Trial locations and contacts
1 site in 1 country.
About this study
A new wireless axillary thermometer from Raiing Medical uses a proprietary system, iThermonitor (WT701), to provide better estimates of core temperature than a conventional axillary probe. Improvement results in part because the axillary probe measures and records temperatures continuously every 4 seconds and includes software to compensate for ambient temperature and positional changes including arm abduction.
Whether the iThermonitor is sufficiently accurate for clinical use remains unknown. The investigators thus propose to evaluate the system in perioperative patients who often experience thermal perturbations over a range of several °C. Specifically, the investigators propose to determine the precision and accuracy of iThermonitor in surgical patients and during the initial hour of recovery. As in previous studies, the investigators will consider the thermometer sufficiently accurate for clinical use if most Raiing temperatures are within ±0.5°C of the reference temperature.
Read the detailed description
Patient characteristics, including age, height, weight, sex, and ASA status, and details of the surgery, including procedure and postoperative diagnosis will be recorded. The investigator will record the time of anesthesia induction and emergence. At 10-minute intervals during surgery, the investigator will record inspired volatile anesthetic concentration, mean-arterial pressure, type of thermal management device(s), and urine output over the previous 10-minute interval.
After induction of general anesthesia (without restriction as to type), the anesthesiologist will insert a temperature sensor into the distal esophagus. The distance will be determined by maximal heart sounds (if a stethoscope is used), or the probe will be inserted 0.48.(sitting height) - 4.4 cm. If an esophageal probe cannot be used, a thermometer can be inserted to between 10 and 20 cm into the nasopharynx. The surgical team will position a Foley catheter with temperature sensor into the urinary bladder. Ambient temperature will be recorded from an electronic probe situated at the height of the patients, well away from any heat-producing equipment.
Axillary temperature will be recorded by iThermonitor, a Raiing Medical wireless module, paired to an iPhone. An adhesive patch provided by Raiing will be used to securely position the Railing probe in a shaved axilla before the anesthesia induction. Patients will be asked to adduct the ipsilateral arm for up to 5 minutes after the probe is inserted, or until the temperature displayed on the paired iPhone is stable. Thereafter, patients will be free to move their arms.Monitored arm position during surgery will be recorded (arm tightly tucked, arm loose at side, arm abducted).
Temperatures will be recorded at 10-minute intervals during surgery and during the initial postoperative hour. Just before anesthetic emergence, the esophageal or nasopharyngeal thermometer will be removed, but the Foley catheter retained. The axillary device will then be removed after an hour of recovery, and the study concluded. The Foley catheter can be removed or retained per clinical need.
- Conditions
- Major Surgery Under General Anesthesia
- Being tested
- iThermonitor (WT701)
- Keywords
- open abdominal surgery, anesthesia, general
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iThermonitor (WT701)Device
Continuously monitor the axillary temperature during surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery Patients >1.5 Hrs | Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring Receives: Device: iThermonitor (WT701) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of iThermonitor in Surgical Patients
Accuracy, defined as the true difference between reference and iThermonitor temperature. The esophageal temperature will be the core temperature reference during surgery.
The primary outcome measure is the proportion of iThermonitor measurements for a patient that are within 0.5° C of the reference will be calculated, and this proportion (median, quartiles, 95% CI) will be summarized across patients.
The Secondary outcome measure are bias and 95% CIs determined by repeated-measures Bland-Altman analysis.
For each patient the average difference between the iThermometer and the reference temperature will be calculated. Patient iThermonitor measurements will be regressed on patient reference measurements to assess the Pearson correlation and 95% CI between iThermonitor and reference and to estimate the bias (slope) of device versus reference.
Measured: From 1 to 3 hours after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
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.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Major Surgery Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Lijian Pei, Peking Union Medical College Hospital
- Investigators
- Lijian Pei, MD, Principal investigator, Associate Prof. of Dept. of Anesthesiology, PUMCHYuguang Huang, MD, Study chair, Chair of Dept. of Anesthesiology, PUMCHDaniel I Sessler, MD, Study director, Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756910
- Sponsor's protocol ID
- HS-1019
- Status last verified
- Feb 2021
- First submitted
- 3 Apr 2016
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.
PubMed 10691247Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
PubMed 11506130Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.
PubMed 8569362Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
PubMed 8606715Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI, Narzt E, Lackner F. Mild intraoperative hypothermia prolongs postanesthetic recovery. Anesthesiology. 1997 Dec;87(6):1318-23. doi: 10.1097/00000542-199712000-00009.
PubMed 9416715Simon HB. Hyperthermia. N Engl J Med. 1993 Aug 12;329(7):483-7. doi: 10.1056/NEJM199308123290708. No abstract available.
PubMed 8332154Sessler DI. Malignant hyperthermia. J Pediatr. 1986 Jul;109(1):9-14. doi: 10.1016/s0022-3476(86)80563-7. No abstract available.
PubMed 3522838Sessler DI. A proposal for new temperature monitoring and thermal management guidelines. Anesthesiology. 1998 Nov;89(5):1298-300. doi: 10.1097/00000542-199811000-00061. No abstract available.
PubMed 9822041Bissonnette B, Sessler DI, LaFlamme P. Intraoperative temperature monitoring sites in infants and children and the effect of inspired gas warming on esophageal temperature. Anesth Analg. 1989 Aug;69(2):192-6.
PubMed 2764288Cork RC, Vaughan RW, Humphrey LS. Precision and accuracy of intraoperative temperature monitoring. Anesth Analg. 1983 Feb;62(2):211-4.
PubMed 6829923Sessler DI. Temperature monitoring and management during neuraxial anesthesia. Anesth Analg. 1999 Feb;88(2):243-5. doi: 10.1097/00000539-199902000-00003. No abstract available.
PubMed 9972734Amoateng-Adjepong Y, Del Mundo J, Manthous CA. Accuracy of an infrared tympanic thermometer. Chest. 1999 Apr;115(4):1002-5. doi: 10.1378/chest.115.4.1002.
PubMed 10208200Suleman MI, Doufas AG, Akca O, Ducharme M, Sessler DI. Insufficiency in a new temporal-artery thermometer for adult and pediatric patients. Anesth Analg. 2002 Jul;95(1):67-71, table of contents. doi: 10.1097/00000539-200207000-00012.
PubMed 12088945Harioka T, Matsukawa T, Ozaki M, Nomura K, Sone T, Kakuyama M, Toda H. "Deep-forehead" temperature correlates well with blood temperature. Can J Anaesth. 2000 Oct;47(10):980-3. doi: 10.1007/BF03024869.
PubMed 11032273