Perioperative HypothermiaNCT07613203
Forced-Air Warming for Preventing Perioperative Hypot
A study testing Forced-Air Warming and Routine Passive Warming in people with Perioperative Hypothermia and Total Knee Arthroplasty, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Perioperative Hypothermia, Total Knee Arthroplasty
- What is being tested?
- Forced-Air Warming and Routine Passive Warming
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Jan 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 85 years
- ASA physical status I or II
- Diagnosed with knee osteoarthritis
- Undergoing first unilateral primary total knee arthroplasty
- Able to provide written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study
Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA.
A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.
Read the detailed description
This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA).
A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period.
The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter.
The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection.
This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.
- Conditions
- Perioperative Hypothermia, Total Knee Arthroplasty
- Being tested
- Forced-Air Warming, Routine Passive Warming
- Keywords
- Forced-Air Warming, Total Knee Arthroplasty, Perioperative Hypothermia, Temperature Management, Anesthesia Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-Air WarmingDevice
Active perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit.
Routine Passive WarmingOther
Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.
| Study group | Role | What they receive |
|---|---|---|
| Forced-Air Warming Group | Experimental | Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period. Receives: Device: Forced-Air Warming |
| Routine Warming Group | Active comparator | Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage. Receives: Other: Routine Passive Warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Inadvertent Perioperative Hypothermia
The proportion of participants with core body temperature below 36.0°C at any perioperative time point.
Measured: From anesthesia induction to 90 minutes after anesthesia completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 May 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Why it stopped: The study was terminated because the principal investigator transferred to another institution, and the original sponsor institution is no longer responsible for this clinical study. Consequently, the original ethics approval is no longer applicable,
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to two groups according to the study period. The historical control group received routine passive warming, and the intervention group received additional forced-air warming.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DanLing Fang, Shanghai 6th People's Hospital
- Investigators
- Danling Fang, RN, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613203
- Sponsor's protocol ID
- TKA-FAW-2018-01
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves retrospective clinical data and institutional privacy restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study
- ClinicalTrials.gov ID
- NCT07613203
- Acronym / sponsor ID
- TKA-FAW-2018-01
- Conditions
- Perioperative Hypothermia, Total Knee Arthroplasty
- Keywords
- Forced-Air Warming, Total Knee Arthroplasty, Perioperative Hypothermia, Temperature Management, Anesthesia Recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because the principal investigator transferred to another institution, and the original sponsor institution is no longer responsible for this clinical study. Consequently, the original ethics approval is no longer applicable,
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 29 May 2026 (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.
Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA.
A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.
Detailed description
This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA).
A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period.
The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter.
The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection.
This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to two groups according to the study period. The historical control group received routine passive warming, and the intervention group received additional forced-air warming.
| Arm | Type | Receives |
|---|---|---|
| Forced-Air Warming Group | Experimental | Device: Forced-Air WarmingParticipants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period. |
| Routine Warming Group | Active comparator | Other: Routine Passive WarmingParticipants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 60 and 85 years
- ASA physical status I or II
- Diagnosed with knee osteoarthritis
- Undergoing first unilateral primary total knee arthroplasty
- Able to provide written informed consent
Key exclusion criteria (0 listed)
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 WarmingActive perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit. | Device | Forced-Air Warming Group |
| Routine Passive WarmingRoutine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. | Other | Routine Warming Group |
Primary outcome
Incidence of Inadvertent Perioperative Hypothermia
Time frame: From anesthesia induction to 90 minutes after anesthesia completion
The proportion of participants with core body temperature below 36.0°C at any perioperative time point.
Results and safety
The study was stopped early (reason given: The study was terminated because the principal investigator transferred to another institution, and the original sponsor institution is no longer responsible for this clinical study. Consequently, the original ethics approval is no longer applicable,). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves retrospective clinical data and institutional privacy restrictions.
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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.
Danling Fang, RN principal investigator
Shanghai 6th People's 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 and Routine Passive Warming in people with Perioperative Hypothermia and Total Knee Arthroplasty, run by Shanghai 6th People's Hospital at 1 site in China.
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 5 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Jul 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 China. 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 was stopped early (reason given: The study was terminated because the principal investigator transferred to another institution, and the original sponsor institution is no longer responsible for this clinical study. Consequently, the original ethics approval is no longer applicable,). Results are not available in the source record.
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?
Incidence of Inadvertent Perioperative Hypothermia (time frame: From anesthesia induction to 90 minutes after anesthesia completion). 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 14 Jul 2026.