Preventing HypothermiaNCT01858727
The Effect of Preoperative Warming on Postoperative Hypothermia
A study testing forced air warming group in people with Preventing Hypothermia and Perioperative Hypothermia, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Preventing Hypothermia, Perioperative Hypothermia
- What is being tested?
- forced air warming group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Jul 2019
- Phase
- Interventional
- 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 50 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- vascular disease,
- poor cutaneous perfusion,
- serious skin lesions
- baseline temperature ≥37.5°C (degrees centigrade)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Teaching and Research Hospital
Ankara, Altindag
About this study
Official title: The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery
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.
Read the 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.
- Conditions
- Preventing Hypothermia, Perioperative Hypothermia
- Being tested
- forced air warming group, control group
- Keywords
- forced-air, hypothermia, TUR-P surgery, core temperatures, prewarming, general anaesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forced air warming groupOther
30 minutes before the preoperative will use forced air warming
control groupOther
do not heating group
| Study group | Role | What they receive |
|---|---|---|
| forced air warming group | Active comparator | 30 minutes before the preoperative will use forced air warming. Receives: Other: forced air warming group; Other: control group |
| control group | No intervention | do not active heating group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-3 hours
Secondary outcomes (3)
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.
Measured: 2-3 hours
Evaluation of hemodynamic variables (heart rate)
heart rate (HR) in beats per minute will be measured.
Measured: 2-3 hours
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.
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start1 Nov 2018
- Primary completion1 Feb 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventing HypothermiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- fakelma 905327079113, Principal investigator, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858727
- Sponsor's protocol ID
- ESM0606
- Status last verified
- Oct 2019
- First submitted
- 13 May 2013
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery
- ClinicalTrials.gov ID
- NCT01858727
- Acronym / sponsor ID
- ESM0606
- Conditions
- Preventing Hypothermia, Perioperative Hypothermia
- Keywords
- forced-air, hypothermia, TUR-P surgery, core temperatures, prewarming, general anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 21 May 2013 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| forced air warming group | Active comparator | Other: forced air warming group, Other: control group30 minutes before the preoperative will use forced air warming. |
| control group | No intervention | –do not active heating group |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| forced air warming group30 minutes before the preoperative will use forced air warming | Other | forced air warming group |
| control groupdo not heating group | Other | forced air warming group |
Primary outcome
Perioperative measurements of core temperature (centigrade ° C)
Time frame: 2-3 hours
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.
3 secondary outcomes
Evaluation of hemodynamic variables (arterial blood pressure)
Time frame: 2-3 hours
Evaluation of hemodynamic variables (heart rate)
Time frame: 2-3 hours
Number of patients with postoperative shivering
Time frame: 2-3 hours
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 8 Oct 2019.
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.
fakelma 905327079113 principal investigator
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forced air warming group in people with Preventing Hypothermia and Perioperative Hypothermia, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 10 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 8 Oct 2019. 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 Turkey (Türkiye). 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?
Perioperative measurements of core temperature (centigrade ° C) (time frame: 2-3 hours). 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 8 Oct 2019.