HypothermiaNormothermiaNCT04011462
Perioperative Normothermia: Temperature and Prewarming Methods
A study testing prewarming 20 minutes and prewarming 30 minutes in people with Hypothermia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- prewarming 20 minutes and prewarming 30 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2019to 30 Mar 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over at the time of data collection
- Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour
Who cannot join
- Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
- Patients submitted to video laparoscopic or minimally invasive surgeries
Trial locations and contacts
1 site in 1 country.
About this study
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).
Read the detailed description
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)
- Conditions
- Hypothermia
- Being tested
- prewarming 20 minutes, prewarming 30 minutes
- Keywords
- Nursing, Hypothermia, Perioperative Nursing
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prewarming 20 minutesDevice
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.
prewarming 30 minutesDevice
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Prewarming 20 minutes | Experimental | prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes. Receives: Device: prewarming 20 minutes |
| Prewarming 30 minutes | Experimental | prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes. Receives: Device: prewarming 30 minutes |
| Standard care | No intervention | warming with cotton sheet and blanket for 20 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to number of patients with temperature below 36 degrees measured by the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period).
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa de Brito Poveda, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011462
- Sponsor's protocol ID
- VPoveda
- Acronym
- Normothermia
- Status last verified
- Sep 2021
- First submitted
- 21 May 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Normothermia: Temperature and Prewarming Methods
- ClinicalTrials.gov ID
- NCT04011462
- Acronym / sponsor ID
- Normothermia / VPoveda
- Conditions
- Hypothermia
- Keywords
- Nursing, Hypothermia, Perioperative Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- 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.
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).
Detailed description
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prewarming 20 minutes | Experimental | Device: prewarming 20 minutesprewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes. |
| Prewarming 30 minutes | Experimental | Device: prewarming 30 minutesprewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes. |
| Standard care | No intervention | –warming with cotton sheet and blanket for 20 minutes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and over at the time of data collection
- Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour
Key exclusion criteria (2 listed)
- Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
- Patients submitted to video laparoscopic or minimally invasive surgeries
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 |
|---|---|---|
| prewarming 20 minutesprewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes. | Device | Prewarming 20 minutes |
| prewarming 30 minutesprewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes. | Device | Prewarming 30 minutes |
Primary outcome
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer
Time frame: Perioperative period
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to number of patients with temperature below 36 degrees measured by the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period).
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 4 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prewarming 20 minutes and prewarming 30 minutes in people with Hypothermia, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 2 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 4 May 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 Brazil. 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?
Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer (time frame: Perioperative period). 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 4 May 2026.