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Perioperative HypothermiaNCT07857538

Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery

A study testing Preoperative Forced-Air Warming in people with Perioperative Hypothermia, run by Çiğdem Ünal Kantekin at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will examine whether warming patients before colon resection surgery improves blood flow in the fingers during early recovery from general anesthesia. It will also compare two warming durations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Perioperative Hypothermia
What is being tested?
Preoperative Forced-Air Warming
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2026to 15 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Scheduled for elective colon resection surgery under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Willing to participate and able to provide written informed consent.

Who cannot join

  • Age younger than 18 years.
  • Emergency surgery.
  • Severe vascular disease that may affect peripheral circulation, such as advanced peripheral arterial disease.
  • Severe cardiovascular instability.
  • Fever (>38 degrees Celsius) or hypothermia (<36 degrees Celsius) before surgery.
  • Severe anemia (hemoglobin <8 g/dL).
Show all 9Show fewer
  • Requirement for vasopressor or inotropic support.
  • A condition in the measurement limb that prevents perfusion index measurement, such as severe peripheral edema, an intravenous line, or involvement of the surgical field.
  • Refusal to participate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Çiğdem Ünal Kantekin, MD contact

+90 505 443 3056

drcgdm@hotmail.com

Turkey (Türkiye)1 site
  • Kayseri City Hospital

    Kayseri, 38080

    Çiğdem Ünal Kantekin, MD, +90 505 443 3056, drcgdm@hotmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Preoperative Prewarming Duration on Postoperative Perfusion Index in Patients Undergoing Colon Resection Surgery: A Randomized Controlled Trial

This study will examine whether warming patients before colon resection surgery improves blood flow in the fingers during early recovery from general anesthesia. It will also compare two warming durations. A total of 108 adults scheduled for elective colon resection surgery at Kayseri City Hospital will be assigned by chance to one of three groups: 10 minutes of warming before anesthesia, 30 minutes of warming before anesthesia, or no active warming before anesthesia. All three groups will receive warming during surgery as part of routine care.

Warming will be provided using a forced-air warming system. After surgery, a sensor placed on a finger will measure the perfusion index, a noninvasive indicator of blood flow, on arrival in the recovery unit and 5 and 10 minutes later. The main comparison will use the average of these three measurements. The researchers will also assess other circulation measurements, routine blood gas and lactate results, shivering, pain, the time until oral feeding begins, and wound infection during the 14 days after surgery.

Read the detailed description

This prospective, single-center, randomized controlled study will be conducted by the Department of Anesthesiology and Reanimation at Kayseri City Hospital. Adults undergoing elective colon resection under general anesthesia will be randomized in a 1:1:1 ratio using a computer-generated randomization list. Allocation will be concealed in sequentially numbered, sealed opaque envelopes opened before the preoperative intervention. The planned sample size is 108 participants, with 36 participants per group.

Active prewarming will be applied in the preoperative preparation area using a forced-air warming system covering the upper and lower body. Device settings will follow manufacturer recommendations and institutional clinical standards. The two prewarming groups will receive 10 or 30 minutes of active warming before anesthesia. The control group will receive routine preoperative care without active prewarming. All groups will receive intraoperative warming and standard anesthesia monitoring and management.

Perfusion index and pleth variability index will be measured noninvasively using a pulse oximeter at postanesthesia care unit (PACU) admission and at 5 and 10 minutes. The primary analysis will compare the arithmetic mean of the three postoperative perfusion index measurements between groups. Arterial blood gas and lactate results will be obtained from routine clinical testing without an additional invasive procedure for research. Demographic characteristics, ASA physical status, anesthesia and surgical duration, perioperative temperature, and relevant intraoperative clinical variables will be recorded.

The primary outcome will be compared using one-way analysis of variance when distributional assumptions are met, or the Kruskal-Wallis test otherwise, with appropriate post-hoc comparisons. Repeated perfusion index measurements will also be examined for group and time effects. Secondary continuous and categorical outcomes will be analyzed with methods appropriate to their distributions. Associations of perfusion index with lactate, blood gas parameters, and pain scores will be examined using Pearson or Spearman correlation. Statistical significance will be set at p < 0.05.

The outcome assessor will be blinded to group assignment. Postoperative pain will be assessed using a 0-10 visual analogue scale at PACU admission and at 5 and 10 minutes. Wound infection will be assessed during the 14-day period following surgery.

Being tested
Preoperative Forced-Air Warming
Keywords
Prewarming, Colon resection, Perfusion index, Pleth variability index, Forced-air warming

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Forced-Air WarmingDevice

    Active warming using a forced-air warming system in the preoperative preparation area before general anesthesia. The upper and lower body are warmed for 10 or 30 minutes according to randomized group assignment. Device temperature settings follow manufacturer recommendations and institutional clinical standards.

Study groups in NCT07857538
Study groupRoleWhat they receive
10-Minute PrewarmingExperimentalParticipants receive 10 minutes of active forced-air warming in the preoperative preparation area before induction of general anesthesia. Warming covers the upper and lower body, with settings following manufacturer recommendations and institutional standards. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.
Receives: Device: Preoperative Forced-Air Warming
30-Minute PrewarmingExperimentalParticipants receive 30 minutes of active forced-air warming in the preoperative preparation area before induction of general anesthesia. Warming covers the upper and lower body, with settings following manufacturer recommendations and institutional standards. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.
Receives: Device: Preoperative Forced-Air Warming
Control: No PrewarmingNo interventionParticipants receive routine preoperative care without active prewarming before induction of general anesthesia. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Postoperative Perfusion Index

    Perfusion index (PI) is measured noninvasively using a pulse oximeter at postanesthesia care unit (PACU) admission, 5 minutes, and 10 minutes. The primary outcome is the arithmetic mean of these three measurements. PI reflects the ratio of the pulsatile to nonpulsatile component of the photoplethysmographic signal and is used as an indicator of peripheral perfusion.

    Measured: At PACU admission and 5 and 10 minutes after admission

Secondary outcomes (12)
  1. Postoperative Pleth Variability Index

    Pleth variability index (PVI) is measured noninvasively using a pulse oximeter at PACU admission, 5 minutes, and 10 minutes to compare early postoperative changes among the three study groups.

    Measured: At PACU admission and 5 and 10 minutes after admission

  2. Postoperative Arterial Lactate

    Arterial lactate concentration, reported in mmol/L, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission. No additional arterial sampling is performed solely for this study.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  3. Postoperative Arterial pH

    Arterial pH obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  4. Postoperative Arterial Carbon Dioxide Partial Pressure

    Arterial carbon dioxide partial pressure (PaCO2), reported in mmHg, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  5. Postoperative Arterial Oxygen Partial Pressure

    Arterial oxygen partial pressure (PaO2), reported in mmHg, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  6. Postoperative Arterial Bicarbonate

    Arterial bicarbonate concentration (HCO3), reported in mmol/L, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  7. Postoperative Arterial Base Excess

    Arterial base excess (BE), reported in mmol/L, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  8. Postoperative Hemoglobin

    Hemoglobin concentration, reported in g/dL, recorded from routine blood gas testing at postanesthesia care unit (PACU) admission.

    Measured: At postanesthesia care unit (PACU) admission (0 minutes)

  9. Postoperative Shivering

    Number of participants with postoperative shivering. Shivering is recorded as present or absent during the first 30 minutes after postanesthesia care unit (PACU) admission.

    Measured: From PACU admission through the first 30 minutes after admission

  10. Time to Initiation of Oral Feeding

    Time from the end of surgery to the first initiation of oral feeding, recorded in hours. Participants are followed for initiation of oral feeding for up to 14 days after surgery.

    Measured: From the end of surgery until initiation of oral feeding, assessed up to 14 days after surgery

  11. Postoperative Pain Score

    Pain intensity assessed using a visual analogue scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores are recorded at PACU admission, 5 minutes, and 10 minutes. Higher scores indicate greater pain.

    Measured: At PACU admission and 5 and 10 minutes after admission

  12. Wound Infection Within 14 Days After Surgery

    Number of participants who develop a wound infection during the 14-day period following surgery. Wound infection is recorded as present or absent.

    Measured: Within 14 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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
Model description
Three parallel groups randomized 1:1:1 to 10 minutes of prewarming, 30 minutes of prewarming, or no active prewarming. All groups receive intraoperative warming. A computer-generated randomization list and sequentially numbered, sealed opaque envelopes are used for allocation concealment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07857538
Sponsor's protocol ID
KCH-PREWARM-2026-1080
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data collected in this study will be made available to other researchers upon reasonable request to the principal investigator.

Publications

  • Shim JW, Kwon H, Moon HW, Chae MS. Clinical Efficacy of 10 Min of Active Prewarming for Preserving Patient Body Temperature during Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial. J Clin Med. 2024 Mar 22;13(7):1843. doi: 10.3390/jcm13071843.

    PubMed 38610608
  • Xiao Y, Zhang R, Lv N, Hou C, Ren C, Xu H. Effects of a preoperative forced-air warming system for patients undergoing video-assisted thoracic surgery: A randomized controlled trial. Medicine (Baltimore). 2020 Nov 25;99(48):e23424. doi: 10.1097/MD.0000000000023424.

    PubMed 33235123
  • Lee S, Kim KS, Park SW, You AH, Lee SW, Kim YJ, Kim M, Lee JY, Choi JH. Correlation between the Perfusion Index and Intraoperative Hypothermia: A Prospective Observational Pilot Study. Medicina (Kaunas). 2021 Apr 8;57(4):364. doi: 10.3390/medicina57040364.

    PubMed 33917932

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Forced-Air Warming in people with Perioperative Hypothermia, run by Çiğdem Ünal Kantekin 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 9 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Çiğdem Ünal Kantekin, MD (+90 505 443 3056, drcgdm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Postoperative Perfusion Index (time frame: At PACU admission and 5 and 10 minutes after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07857538, which also lists 3 linked publications.

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 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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