Hypothermia Following AnesthesiaNCT05213377
Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty
A study testing Preoperative warming in people with Hypothermia Following Anesthesia and Hypothermia; Anesthesia, run by University of Liege at 1 site in Belgium.
Trial summary
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia Following Anesthesia, Hypothermia; Anesthesia
- What is being tested?
- Preoperative warming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jan 2022to 20 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2-3
- Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia
Who cannot join
- pregnant women
- patients with:
- peripheral neuropathy or other severe neurological pathology
- immunosuppression
- chronic renal insufficiency or severe hepatic insufficiency
- major congenital or acquired hemostasis disorders
Show all 9Show fewer
- craniofacial dysmorphism or anatomical alterations of the upper airways
- known thermoregulatory disorders
- patients with a preoperative body temperature > 37.5°C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.
Read the detailed description
In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature.
Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery.
All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients.
The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.
- Being tested
- Preoperative warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative warmingProcedure or surgery
Patients enrolled in surgery who will not receive 30 minutes of pulsed air thermal blanket warming prior to induction of anesthesia (3M™ Bair Hugger™ Adult Integral Blanket, Model 300 Dimensions: 213 cm x 91 cm)
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Patients undergoing total hip replacement surgery by anterior approach, with general anesthesia and continuous core body temperature measurement via nasopharyngeal thermic probe. Patients recruited for surgery who will not receive the 30 minutes of preoperative warming through pulsed air thermal coverage. |
| Group W | Experimental | Patients undergoing total hip replacement surgery by anterior approach, with general anesthesia and continuous core body temperature measurement via nasopharyngeal thermic probe.
Patients recruited for surgery who will receive the 30 minutes of preoperative warming through pulsed air thermal coverage. Receives: Procedure: Preoperative warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Variation of core body temperature during surgery, i.e. the difference between the temperature at the time of induction of general anaesthesia and the minimum temperature recorded during the procedure, as well as its evolution over time.
Measured: Intraoperative
Secondary outcomes (8)
Intraoperative blood loss
Total intraoperative blood loss
Measured: Intraoperative
Shivering
The incidence of shivering in the first 6 hours post-surgery
Measured: First 6 hours after surgery
Patient comfort
Comfort in the recovery room by visual analogical scale (VAS 0-100)
Measured: First 6 hours after surgery
Patient comfort
Length of stay in the recovery room
Measured: First 6 hours after surgery
Surgical site infection
Incidence of surgical site infection at 30 days postoperative
Measured: 30 days after surgery
Postoperative complications
The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)
Measured: 3 days after surgery
QoR-15
Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)
Measured: Day-1 and Day-3 after surgery
LoS
Length of stay in hospital
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start5 Jan 2022
- Primary completion19 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypothermia Following AnesthesiaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Carella, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213377
- Sponsor's protocol ID
- Thermo-ATHA22
- Status last verified
- Nov 2022
- First submitted
- 3 Jan 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126Simpson JB, Thomas VS, Ismaily SK, Muradov PI, Noble PC, Incavo SJ. Hypothermia in Total Joint Arthroplasty: A Wake-Up Call. J Arthroplasty. 2018 Apr;33(4):1012-1018. doi: 10.1016/j.arth.2017.10.057. Epub 2017 Nov 8.
PubMed 29195854Akca O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5.
PubMed 12024079McClain R, Bojaxhi E, Ford S, Hex K, Whalen J, Robards C. Forced-Air Convection Versus Underbody Conduction Warming Strategies to Maintain Perioperative Normothermia in Patients Undergoing Total Joint Arthroplasty. Cureus. 2020 Nov 13;12(11):e11474. doi: 10.7759/cureus.11474.
PubMed 33329970
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05213377
- Acronym / sponsor ID
- Thermo-ATHA22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Jan 2022 (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.
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.
Detailed description
In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature.
Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery.
All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients.
The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Patients undergoing total hip replacement surgery by anterior approach, with general anesthesia and continuous core body temperature measurement via nasopharyngeal thermic probe. Patients recruited for surgery who will not receive the 30 minutes of preoperative warming through pulsed air thermal coverage. |
| Group W | Experimental | Procedure: Preoperative warmingPatients undergoing total hip replacement surgery by anterior approach, with general anesthesia and continuous core body temperature measurement via nasopharyngeal thermic probe. Patients recruited for surgery who will receive the 30 minutes of preoperative warming through pulsed air thermal coverage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-2-3
- Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia
Key exclusion criteria (9 listed)
- pregnant women
- patients with:
- patients with a preoperative body temperature > 37.5°C.
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 |
|---|---|---|
| Preoperative warmingPatients enrolled in surgery who will not receive 30 minutes of pulsed air thermal blanket warming prior to induction of anesthesia (3M™ Bair Hugger™ Adult Integral Blanket, Model 300 Dimensions: 213 cm x 91 cm) | Procedure or surgery | Group W |
Primary outcome
Core body temperature
Time frame: Intraoperative
Variation of core body temperature during surgery, i.e. the difference between the temperature at the time of induction of general anaesthesia and the minimum temperature recorded during the procedure, as well as its evolution over time.
8 secondary outcomes
Intraoperative blood loss
Time frame: Intraoperative
Shivering
Time frame: First 6 hours after surgery
Patient comfort
Time frame: First 6 hours after surgery
Patient comfort
Time frame: First 6 hours after surgery
Surgical site infection
Time frame: 30 days after surgery
Postoperative complications
Time frame: 3 days after surgery
QoR-15
Time frame: Day-1 and Day-3 after surgery
LoS
Time frame: 30 days after surgery
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 10 Nov 2022.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- Background: PubMed 29195854Simpson JB, Thomas VS, Ismaily SK, Muradov PI, Noble PC, Incavo SJ. Hypothermia in Total Joint Arthroplasty: A Wake-Up Call. J Arthroplasty. 2018 Apr;33(4):1012-1018. doi: 10.1016/j.arth.2017.10.057. Epub 2017 Nov 8.
- Background: PubMed 12024079Akca O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5.
- Background: PubMed 33329970McClain R, Bojaxhi E, Ford S, Hex K, Whalen J, Robards C. Forced-Air Convection Versus Underbody Conduction Warming Strategies to Maintain Perioperative Normothermia in Patients Undergoing Total Joint Arthroplasty. Cureus. 2020 Nov 13;12(11):e11474. doi: 10.7759/cureus.11474.
- 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 Preoperative warming in people with Hypothermia Following Anesthesia and Hypothermia; Anesthesia, run by University of Liege at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 Belgium. 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?
Core body temperature (time frame: Intraoperative). 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 NCT05213377, which also lists 4 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 10 Nov 2022.