Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering (THER4-1)
This study has been completed.
Sponsor:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Dr. Jan Hoecker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01234233
First received: September 9, 2010
Last updated: October 10, 2011
Last verified: October 2011
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Purpose
The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.
Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
| Condition | Intervention |
|---|---|
|
Hypothermia |
Procedure: duration of preoperative active warming |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering. |
Resource links provided by NLM:
Further study details as provided by University of Schleswig-Holstein:
Primary Outcome Measures:
- Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU) [ Time Frame: postoperative arrival at PACU (once) ] [ Designated as safety issue: No ]After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.
Secondary Outcome Measures:
- Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients. [ Time Frame: preoperatively (once) at arrival at PACU ] [ Designated as safety issue: No ]Sublingual and tympanic body temperature will be assessed simultaneously once at patients' preoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for assessment of data: one single measurement immediately (1 min) after patients' arrival at PACU. Afterwards: observation of patients for about 2h.
- Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients. [ Time Frame: intraoperatively (30 min after start of surgery), once ] [ Designated as safety issue: No ]Sublingual and tympanic body temperature will be assessed simultaneously (once) 30 min after start of surgery and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 1 min after 30 min after start of surgery.Afterwards patients will be observed for about 3h.
- Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients. [ Time Frame: at postoperative arrival at PACU, once ] [ Designated as safety issue: No ]Sublingual and tympanic body temperature will be assessed simultaneously (once) at patients' postoperative arrival at PACU and compared to each other with analysis of correlation. This means that one sublingual and one tympanic temperature value will be measured to be compared to each other.Time frame for data assessment: 30 sec immediately after patients' arrival at PACU.
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Group 1
Control group - no intervention: no preoperative warming
|
Procedure: duration of preoperative active warming
duration of prewarming by "forced air warming"
|
|
Active Comparator: Group 2 - 10 min prewarming
10 min prewarming preoperatively
|
Procedure: duration of preoperative active warming
duration of prewarming by "forced air warming"
|
|
Active Comparator: Group 3 - 20 min prewarming
20 min prewarming preoperatively
|
Procedure: duration of preoperative active warming
duration of prewarming by "forced air warming"
|
|
Active Comparator: Group 4 - 30 min prewarming
30 min prewarming preoperatively
|
Procedure: duration of preoperative active warming
duration of prewarming by "forced air warming"
|
Detailed Description:
Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.
The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.
The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients scheduled for minor surgery (planned duration approximately <1h).
- Age 18-75yrs,
- ASA I-II physical status
Exclusion Criteria:
- Emergency surgery,
- pregnant patients,
- patients not able to give informed consent,
- duration of surgery >2h,
- necessary postoperative mechanical ventilation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234233
Locations
| Germany | |
| UK-SH, Campus Kiel | |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Klinikum Pinnerberg, Dep. of Anaesthesiology | |
| Pinneberg, Schleswig-Holstein, Germany, 25421 | |
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
| Study Director: | Markus Steinfath, M.D. | Dep. of Anaesthesiology, UK-SH, Campus Kiel |
| Principal Investigator: | Ernst P Horn, M.D. | Klinikum Pinnerberg, Pinneberg, Germany |
| Principal Investigator: | Jan Höcker, M.D. | Dep. of Anaesthesiology, UK-SH, Campus Kiel |
| Study Chair: | Berthold Bein, M.D. | Dep. of Anaesthesiology, UK-SH, Campus Kiel |
More Information
No publications provided by University of Schleswig-Holstein
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Jan Hoecker, PD Dr. Jan Höcker, University of Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT01234233 History of Changes |
| Other Study ID Numbers: | THER-JH |
| Study First Received: | September 9, 2010 |
| Last Updated: | October 10, 2011 |
| Health Authority: | Germany: Ministry of Health |
Keywords provided by University of Schleswig-Holstein:
|
hypothermia, accidental prewarming body temperature monitoring |
preoperative warming sublingual temperature assessment tympanic temperature assessment |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013