Back to resultsThe Effect of Preoperative Warming on Postoperative Hypothermia
Primary Purpose
Preventing Hypothermia, Perioperative Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
forced air warming group
control group
Sponsored by
About this trial
This is an interventional supportive care trial for Preventing Hypothermia focused on measuring forced-air, hypothermia, TUR-P surgery, core temperatures, prewarming, general anaesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients aged 50-85 years undergoing general anesthesia for TURP surgery
- ASA physical status I and III patients
- Body mass index between 15 and 36 kg/m2
- General anesthesia time is 30-90 minutes
Exclusion Criteria:
- without written consent,
- inadequate Turkish comprehension,
- known impaired thermoregulation or thyroid disorders,
- severe hypertension (systolic blood pressure [SBP]>180 mmHg or diastolic blood pressure [DBP] > 110 mmHg in the operating suite admission),
- an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,
- secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),
- vascular disease,
- poor cutaneous perfusion,
- serious skin lesions
- baseline temperature ≥37.5°C (degrees centigrade)
Sites / Locations
- Diskapi Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
forced air warming group
control group
Arm Description
30 minutes before the preoperative will use forced air warming.
do not active heating group
Outcomes
Primary Outcome Measures
Perioperative measurements of core temperature (centigrade ° C)
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature < 36°C)will be measured.
Secondary Outcome Measures
Evaluation of hemodynamic variables (arterial blood pressure)
systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean arterial pressure (MAP) in mmHg will be measured.
Evaluation of hemodynamic variables (heart rate)
heart rate (HR) in beats per minute will be measured.
Number of patients with postoperative shivering
After the operation patients will be admitted to the PACU. Here, postoperative shivering will be measured and graded by visual inspection.
Full Information
NCT ID
NCT01858727
First Posted
May 13, 2013
Last Updated
October 5, 2019
Sponsor
Ankara Diskapi Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01858727
Brief Title
The Effect of Preoperative Warming on Postoperative Hypothermia
Official Title
The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will be included in the study. Patients will be randomized into two groups; first group(control group) and second group (forced-air warming). Resistive heating will start when patients are transferred to the operating room table; forced-air warming will start before preoperative 30 minute.
Detailed Description
The primary aim of this study was to compare the effect of prewarming on perioperative hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time, tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2 groups. Body temperature will be measured at the core temperature, hemodynamic variables. Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction will be evaluated. The investigators hypothesize will decrease the forced air prewarming incidence of perioperative hypothermia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventing Hypothermia, Perioperative Hypothermia
Keywords
forced-air, hypothermia, TUR-P surgery, core temperatures, prewarming, general anaesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
forced air warming group
Arm Type
Active Comparator
Arm Description
30 minutes before the preoperative will use forced air warming.
Arm Title
control group
Arm Type
No Intervention
Arm Description
do not active heating group
Intervention Type
Other
Intervention Name(s)
forced air warming group
Intervention Description
30 minutes before the preoperative will use forced air warming
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
do not heating group
Primary Outcome Measure Information:
Title
Perioperative measurements of core temperature (centigrade ° C)
Description
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature < 36°C)will be measured.
Time Frame
2-3 hours
Secondary Outcome Measure Information:
Title
Evaluation of hemodynamic variables (arterial blood pressure)
Description
systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean arterial pressure (MAP) in mmHg will be measured.
Time Frame
2-3 hours
Title
Evaluation of hemodynamic variables (heart rate)
Description
heart rate (HR) in beats per minute will be measured.
Time Frame
2-3 hours
Title
Number of patients with postoperative shivering
Description
After the operation patients will be admitted to the PACU. Here, postoperative shivering will be measured and graded by visual inspection.
Time Frame
2-3 hours
Other Pre-specified Outcome Measures:
Title
To assess patient satisfaction
Description
patient satisfaction scale (using a Likert scale type (range, 1 to 7) verbally administered questionnaire for patient satisfaction)
Time Frame
12 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged 50-85 years undergoing general anesthesia for TURP surgery
ASA physical status I and III patients
Body mass index between 15 and 36 kg/m2
General anesthesia time is 30-90 minutes
Exclusion Criteria:
without written consent,
inadequate Turkish comprehension,
known impaired thermoregulation or thyroid disorders,
severe hypertension (systolic blood pressure [SBP]>180 mmHg or diastolic blood pressure [DBP] > 110 mmHg in the operating suite admission),
an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,
secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),
vascular disease,
poor cutaneous perfusion,
serious skin lesions
baseline temperature ≥37.5°C (degrees centigrade)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fakelma 905327079113
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Teaching and Research Hospital
City
Ankara
State/Province
Altindag
Country
Turkey
12. IPD Sharing Statement
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The Effect of Preoperative Warming on Postoperative Hypothermia
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