Nursing CariesNCT04907617
The Effect of Active Warming During General Anaesthesia on Postoperative Body Temperature, Shivering and Thermal Comfort
A study testing FAW, Warmed fluids and Combination in people with Nursing Caries and Postoperative Pain, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- FAW, Warmed fluids and Combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2020to 18 Dec 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over the age of 18 Receiving general anesthesia, surgery time ≥ 1 hour in the American Society of Anesthesiologists (ASA) I-III class Not having any obstacle to make communication difficult İnformed written consent to participate in the study.
Who cannot join
- Having surgery with local anesthesia Preoperative body temperature ≥38 0C or <36 0C Unapplied therapeutic hypothermia during the operation, Systemic infection in the patient, Mental retardation, Serious head injury, Brain damage disruption in temperature regulation, Taking medication to affect thermoregulation Unapplied IV fluids up to one hour before anesthesia induction.
- Exclusion criteria is exitus and worsening for any reason in the general condition during and after the surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özlem
Yozgat
Özlem Şahin Akboğa, 5396848180, ozlemsahin.os17@gmail.com
Aysel Gürkan, Prof. Dr.
About this study
Official title: The Effect of Active Warming During General Anaesthesia on Postoperative Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting in Adult Patients: A Randomised Controlled Trial Protocol
Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia. This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.
Read the detailed description
Background: Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia.
Objective: This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.
Design and setting: This is a single centre randomised controlled clinical trial. A 2 x 2 factorial design will used in the experiment. Eligible patients will be randomly assigned to one of four groups.
Methods: After the induction of anaesthesia, forced-air warming as well as warmed intravenous (IV) and irrigation fluids will be applied to the first group, the second group will be warmed with only forced-air warming device, the third group will receive only warmed intravenous and irrigation fluids, and the fourth group will consist of the control group without any intervention. Blood and blood products to be applied intraoperatively to all groups will be heated to 37°C. The primary outcome measures are postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting. The primary results will be subjected to a two-way analysis of variance for covariants such as ambient temperature and volume of intraoperative fluids.
Participants: The trial will include patients aged ≥18 years who underwent surgery under general anaesthesia, whose duration of surgery was >1 hour, who belong to the class of American Society of Anesthesiologists I-III, who do not have any disability that would make communication difficult, and who provide written informed consent to participate in the study.
Discussion: The trial is designed to validate the effectiveness of these two interventions administered alone and in combination in maintaining perioperative normothermia and to assess whether they translate into improved patient outcomes.
- This trial is being carried out as Marmara University Institute of Health Sciences Doctorate Thesis in Nursing.
Funding: No funding
- Being tested
- FAW, Warmed fluids, Combination, Control
- Keywords
- Perioperative Nursing, Body Temperature, Hypothermia, Shivering, Pain, Postoperative Nausea and Vomiting
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Hypothermia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAWOther
After the induction of anaesthesia, for patients assigned to groups 1 and 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C.
Warmed fluidsOther
In patients assigned to groups 2 and 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet.
CombinationOther
After the induction of anaesthesia, for patients assigned to groups 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C.
In patients assigned to groups 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet.
ControlOther
The patients assigned to group 4 will only receive 'routine care'. They will not be given intraoperative forced-air warming or heated IV and irrigation fluids.
| Study group | Role | What they receive |
|---|---|---|
| G1 | Experimental | After the induction of anaesthesia, the first group will be heated with only forced-air warming device. Receives: Other: FAW |
| G2 | Experimental | After the induction of anaesthesia, the second group will receive only warmed IV and irrigation fluids. Receives: Other: Warmed fluids |
| G3 | Experimental | After the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the third group Receives: Other: Combination |
| G4 | Experimental | After the induction of anaesthesia, the fourth group will be the control group without any intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
In the trial, the body temperature of the participants will be measured with a tympanic thermometer (Braun ThermoScan® 3, IRT 3030, Mexico, USA).
Measured: two days
Thermal comfort scale
The thermal comfort of the patients will be measured with a 100-point thermal comfort scale based on self-reporting. The patients will be asked to score how comfortable they are with their body temperature [0 = extremities too cold; 50 = no discomfort (shivering or sweating); 100 = extremities too hot] on a scale of 0-100 points (Cobb et al., 2016). This numerical rating scale has been used effectively in previous studies on thermal comfort
Measured: two days
Shivering
Shivering will be assessed using a 4-point bedside shivering assessment scale developed by Badjatia et al. (2008) [0 = no shivering; 1 = mild (shivering localised in the neck/thorax, only visible as an artefact on EEG or can be noted on palpation); 2 = moderate (intermittent shivering in the upper extremities ± thorax); 3 = severe (diffuse shivering or continuous shivering in the upper/lower extremities)]
Measured: two days
Postoperative pain
The postoperative pain of the patients will be assessed with the Numerical Rating Scale (NRS) based on self-reporting. The obtained NRS score will be considered as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain (Chou et al., 2016; Van Dijk et al., 2012).
Measured: two days
Postoperative nausea and vomiting
Based on a previous study, the presence of postoperative nausea and vomiting of the patients in the trial will be considered as follows: 0 = no nausea; 1 = nausea without vomiting; 2 = nausea with vomiting.
Measured: two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start18 Dec 2020
- Primary completion18 Sep 2021 (estimated)
- Study completion18 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies 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
- Factorial
- Model description
- The participants in the study will be allocated to one of four groups. In the trial, the participants will be assigned to the interventions and registered by the first author of this study.After the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the first group, the second group will be heated with only forced-air warming device, the third group will receive only warmed IV and irrigation fluids, and the fourth group will be the control group without any intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sahin Akboga, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907617
- Sponsor's protocol ID
- marmarabozok
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not suitable for making individual participant data (IPD) available to other researchers.
Publications
Sahin Akboga O, Gurkan A. Effects of Active Heating Methods on Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting During General Anesthesia: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Dec;14(4):269-281. doi: 10.1089/ther.2023.0049. Epub 2023 Nov 24.
PubMed 38011688
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Warming During General Anaesthesia on Postoperative Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting in Adult Patients: A Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04907617
- Acronym / sponsor ID
- marmarabozok
- Keywords
- Perioperative Nursing, Body Temperature, Hypothermia, Shivering, Pain, Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 18 Sep 2021 (estimated)
- Study completion
- 18 Dec 2021 (estimated)
- First posted
- 1 Jun 2021 (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.
Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia. This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.
Detailed description
Background: Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia.
Objective: This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.
Design and setting: This is a single centre randomised controlled clinical trial. A 2 x 2 factorial design will used in the experiment. Eligible patients will be randomly assigned to one of four groups.
Methods: After the induction of anaesthesia, forced-air warming as well as warmed intravenous (IV) and irrigation fluids will be applied to the first group, the second group will be warmed with only forced-air warming device, the third group will receive only warmed intravenous and irrigation fluids, and the fourth group will consist of the control group without any intervention. Blood and blood products to be applied intraoperatively to all groups will be heated to 37°C. The primary outcome measures are postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting. The primary results will be subjected to a two-way analysis of variance for covariants such as ambient temperature and volume of intraoperative fluids.
Participants: The trial will include patients aged ≥18 years who underwent surgery under general anaesthesia, whose duration of surgery was >1 hour, who belong to the class of American Society of Anesthesiologists I-III, who do not have any disability that would make communication difficult, and who provide written informed consent to participate in the study.
Discussion: The trial is designed to validate the effectiveness of these two interventions administered alone and in combination in maintaining perioperative normothermia and to assess whether they translate into improved patient outcomes.
- This trial is being carried out as Marmara University Institute of Health Sciences Doctorate Thesis in Nursing.
Funding: No funding
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The participants in the study will be allocated to one of four groups. In the trial, the participants will be assigned to the interventions and registered by the first author of this study.After the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the first group, the second group will be heated with only forced-air warming device, the third group will receive only warmed IV and irrigation fluids, and the fourth group will be the control group without any intervention.
| Arm | Type | Receives |
|---|---|---|
| G1 | Experimental | Other: FAWAfter the induction of anaesthesia, the first group will be heated with only forced-air warming device. |
| G2 | Experimental | Other: Warmed fluidsAfter the induction of anaesthesia, the second group will receive only warmed IV and irrigation fluids. |
| G3 | Experimental | Other: CombinationAfter the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the third group |
| G4 | Experimental | Other: ControlAfter the induction of anaesthesia, the fourth group will be the control group without any intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being over the age of 18 Receiving general anesthesia, surgery time ≥ 1 hour in the American Society of Anesthesiologists (ASA) I-III class Not having any obstacle to make communication difficult İnformed written consent to participate in the study.
Key exclusion criteria (2 listed)
- Having surgery with local anesthesia Preoperative body temperature ≥38 0C or <36 0C Unapplied therapeutic hypothermia during the operation, Systemic infection in the patient, Mental retardation, Serious head injury, Brain damage disruption in temperature regulation, Taking medication to affect thermoregulation Unapplied IV fluids up to one hour before anesthesia induction.
- Exclusion criteria is exitus and worsening for any reason in the general condition during and after the 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 |
|---|---|---|
| FAWAfter the induction of anaesthesia, for patients assigned to groups 1 and 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C. | Other | G1 |
| Warmed fluidsIn patients assigned to groups 2 and 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet. | Other | G2 |
| CombinationAfter the induction of anaesthesia, for patients assigned to groups 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C. In patients assigned to groups 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet. | Other | G3 |
| ControlThe patients assigned to group 4 will only receive 'routine care'. They will not be given intraoperative forced-air warming or heated IV and irrigation fluids. | Other | G4 |
Primary outcome
Body temperature
Time frame: two days
In the trial, the body temperature of the participants will be measured with a tympanic thermometer (Braun ThermoScan® 3, IRT 3030, Mexico, USA).
Thermal comfort scale
Time frame: two days
The thermal comfort of the patients will be measured with a 100-point thermal comfort scale based on self-reporting. The patients will be asked to score how comfortable they are with their body temperature [0 = extremities too cold; 50 = no discomfort (shivering or sweating); 100 = extremities too hot] on a scale of 0-100 points (Cobb et al., 2016). This numerical rating scale has been used effectively in previous studies on thermal comfort
Shivering
Time frame: two days
Shivering will be assessed using a 4-point bedside shivering assessment scale developed by Badjatia et al. (2008) [0 = no shivering; 1 = mild (shivering localised in the neck/thorax, only visible as an artefact on EEG or can be noted on palpation); 2 = moderate (intermittent shivering in the upper extremities ± thorax); 3 = severe (diffuse shivering or continuous shivering in the upper/lower extremities)]
Postoperative pain
Time frame: two days
The postoperative pain of the patients will be assessed with the Numerical Rating Scale (NRS) based on self-reporting. The obtained NRS score will be considered as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain (Chou et al., 2016; Van Dijk et al., 2012).
Postoperative nausea and vomiting
Time frame: two
Based on a previous study, the presence of postoperative nausea and vomiting of the patients in the trial will be considered as follows: 0 = no nausea; 1 = nausea without vomiting; 2 = nausea with vomiting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 38011688Sahin Akboga O, Gurkan A. Effects of Active Heating Methods on Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting During General Anesthesia: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Dec;14(4):269-281. doi: 10.1089/ther.2023.0049. Epub 2023 Nov 24.
- Individual participant dataSharing planned: No. It is not suitable for making individual participant data (IPD) available to other researchers.
Related trials for Nursing Caries
Not yet recruitingPhase 4
Oral Hygiene Assistance Training Program
Elderly, Periodontal Disease
Not yet recruiting
Virtual Escape Room Game About Medical Device in Nurses
Nursing Caries, Pressure Injuries
Recruiting
Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
Periodontitis, Gingivitis
Not yet recruiting
Flipped Learning Model on the Stoma Care
Stoma Colostomy, Nursing Caries
Not yet recruiting
Flipped Learning Model on Nursing Students' Thorax and Heart Examination
Nursing Students, Nursing Caries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAW, Warmed fluids and Combination in people with Nursing Caries and Postoperative Pain, run by Bozok University 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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: two days). The study lists 5 primary outcomes in all. 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 NCT04907617, which also lists 1 linked publication.
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 1 Jun 2021.