Intraoperative TemperatureTePaLaNCT02781194
Temperature and Pain in Laparoscopy
A study testing 3M™ Bair Hugger™ and F&P HumiGard™ Surgical Humidification System in people with Intraoperative Temperature and Postoperative Pain, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration >… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Intraoperative Temperature, Postoperative Pain, Laparoscopy
- What is being tested?
- 3M™ Bair Hugger™ and F&P HumiGard™ Surgical Humidification System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Sep 2018
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or above and aged under 70 years
- Written informed consent prior to study participation
- Patients admitted to hospital for laparoscopic surgery with a planned duration of more than 1 hour; if there is an open component to the surgery then this should be discussed, in terms of the length of the laparoscopic component
- BMI <35
Who cannot join
- Pregnancy or women without sufficient contraception
- Women, who are breastfeeding
- Alcohol or drug abuse
- Expected non-compliance
- Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
- Participation on another interventional study within the last 3 months
- Subjects who are committed to an institution and/or penitentiary by judicial or official order
- Employees of the investigator cooperation companies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: A Prospective, Randomized, Controlled, Study Investigating Intraoperative Temperature and Postoperative Pain Course Following Gynaecological Laparoscopy
The aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration > 60 min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair hugger). Second group will be treated with warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Third group will be treated with both, warming blankets and warmed, humidified insufflation. The peri-operative temperature of patients might be higher in patients of the third group with the combination of both treatments. The investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ between groups. Wound infection incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum will be less.
Read the detailed description
During the first 30 to 40 minutes of anaesthesia, a patient's temperature can drop to below 35.0°C. Reasons for this include loss of the behavioural response to cold and the impairment of thermoregulatory heat-preserving mechanisms under general or regional anaesthesia, anaesthesia-induced peripheral vasodilation, the use of cold dry insufflation gases. For these reasons, institutions employ a range of techniques to prevent hypothermia, including forced air warming (peri-operatively), use of warmed intravenous fluids, temperature monitoring and control of room temperature. Despite these interventions audits demonstrate that 20-56% of patients are hypothermic during the perioperative period. A factor often dismissed as a cause of peri-operative hypothermia during laparoscopic procedures is dry and cold insufflation gas. During laparoscopic procedures the abdomen is continuously insufflated with cold, dry CO2 resulting in desiccation and heat loss which consequently induces hypothermia in the patient. Clinical evidence suggests that the risk of hypothermia can be reduced using warm and humidified gas, as has been shown in animal models, in clinical trials and confirmed in a metaanalysis in humans. Only gas at body temperature and fully saturated with moisture will prevent loss of energy from the peritoneum surface - because it is physically not possible to evaporate fluids into a fully saturated gas. Therefore, the fluid layer will be maintained, minimizing energy loss from the body, decreasing the hypothermia induced by the evaporative losses in laparoscopic surgery and stabilizing the fibrinolytic activity of the peritoneum. The aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration > 60 min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair hugger). Second group will be treated with warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Third group will be treated with both, warming blankets and warmed, humidified insufflation. The peri-operative temperature of patients might be higher in patients of the third group with the combination of both treatments. The investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ between groups. Wound infection incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum will be less.
- Conditions
- Intraoperative Temperature, Postoperative Pain, Laparoscopy
- Being tested
- 3M™ Bair Hugger™, F&P HumiGard™ Surgical Humidification System
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Bair Hugger™Device
forced-air warming blanket
F&P HumiGard™ Surgical Humidification SystemDevice
warmed, humidified insufflation
| Study group | Role | What they receive |
|---|---|---|
| forced-air warming blanket | Experimental | Forced-air warming blanket via 3M™ Bair Hugger™. Receives: Device: 3M™ Bair Hugger™ |
| warmed, humidified insufflation | Experimental | Warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Receives: Device: F&P HumiGard™ Surgical Humidification System |
| forced-air warming blanket & warmed, humidified insufflation | Experimental | Combination of forced-air warming blanket via 3M™ Bair Hugger™ and warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Receives: Device: 3M™ Bair Hugger™; Device: F&P HumiGard™ Surgical Humidification System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative core temperature
Intra-operative core temperature measured via oesophageal probe/urinary catheter after anaesthetic induction (baseline) but before insufflation and at 10 minute intervals until completion of surgery; hypothermia (<36 C) during the peri-operative period to be indicated by:
- Mild (core temperature 35.0 °C to 35.9 °C)
- Moderate (34.0 °C to 34.9 °C)
- Severe ≤33.9 °C)
Measured: 2 hours
Body temperature
Body temperature as measured by direct tympanic thermometer:
- Pre-operatively - 1 hour before induction and at 10 minute intervals until induction
- Before anesthetic induction
- Post-operatively at entry to recovery room and at 10 minute intervals or until normo-thermia (≥36.5 °c) is achieved. Time at which normothermia is achieved to be recorded.
Measured: 2 hours
VAS (visual analouge scale): composite measure of pain in different regions of the body
VAS: Pain from abdominal area - Pain in the shoulder
- Pain on movement - Pain on coughing, before transfer to ward; at arrival in recovery room; 8 a.m. + 8 p.m. until discharge; 0 - 10 Numeric Pain Rating Scale by VAS, National Institute of Pain Control - NIPCTM
Measured: up to 7 days
morphine equivalent daily dose (MEDD) usage in patient controlled analgesia (PCA)
MEDD usage: intraoperative, post anaesthesia care unit (PACU), Day 0, Day 1, Day 2, Day 3, Total during admission, Day on which PCA is removed if PCA is used. Start of PCA to be standardised, if possible all patient requests for PCA to be recorded by software, even if patient lockout has occurred due to too many attempts to activate PCA in a certain time.
Measured: up to 7 days
Perioperative Fluid (PV)
PV to be recorded at 10 min intervals perioperatively. Volume of electrolyte solution infused to be recorded, as well as time from induction until infusion takes place.
Measured: 2 hours
Fibrinolytic activity
Fibrinolytic activity in the peritoneal fluid will be determined at the beginning of surgery and Day 1. Sample will be taken from an abdominal drain.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraoperative TemperatureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Wittenborn, Dr. med., Principal investigator, Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781194
- Sponsor's protocol ID
- 13-030
- Acronym
- TePaLa
- Status last verified
- Feb 2018
- First submitted
- 17 May 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
1. Frank S, Fleisher L, Breslow M, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial [see comments]. JAMA 1997; 277(14):1127-34. -- 2. Frank S, Higgins M, Fleisher L, et al. Adrenergic, respiratory, and cardiovascular effects of core cooling in humans. Am J Physiol 1997; 272(2 Pt 2):R557-62. -- 3. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. New England Journal of Medicine 1996; 334(19):1209-1215. -- 4. Hofer CK, Worn M, Tavakoli R, et al. Influence of body core temperature on blood loss and transfusion requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc Surg 2005; 129(4):838-43. -- 5. Johansson T, Lisander B, Ivarsson I. Mild hypothermia does not increase blood loss during total hip arthroplasty. Acta Anaesthesiol Scand 1999; 43(10):1005-10. -- 6. Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial.[see comment][erratum appears in Lancet 2002 Mar 9;359(9309):896]. Lancet 2001; 358(9285):876-80. -- 7. Nesher N, Zisman E, Wolf T, et al. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg 2003; 96(2):328-35, table of contents. -- 8. Persson K, Lundberg J. Perioperative hypothermia and postoperative opioid requirements. Eur J Anaesthesiol 2001; 18(10):679-86. -- 9. Schmied H, Kurz A, Sessler DI, et al. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet 1996; 347(8997):289-92. -- 10. Sellden E. Peri-operative amino acid administration and the metabolic response to surgery. Proc Nutr Soc 2002; 61(3):337-43.
Wittenborn J, Mathei D, van Waesberghe J, Zeppernick F, Zeppernick M, Tchaikovski S, Kowark A, Breuer M, Keszei A, Stickeler E, Zoremba N, Rossaint R, Bruells C, Meinhold-Heerlein I. The effect of warm and humidified gas insufflation in gynecological laparoscopy on maintenance of body temperature: a prospective randomized controlled multi-arm trial. Arch Gynecol Obstet. 2022 Sep;306(3):753-767. doi: 10.1007/s00404-022-06499-z. Epub 2022 Mar 14.
PubMed 35286431Breuer M, Wittenborn J, Rossaint R, Van Waesberghe J, Kowark A, Mathei D, Keszei A, Tchaikovski S, Zeppernick M, Zeppernick F, Stickeler E, Zoremba N, Meinhold-Heerlein I, Bruells C. Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial. Surg Endosc. 2022 Jun;36(6):4154-4170. doi: 10.1007/s00464-021-08742-1. Epub 2021 Oct 1.
PubMed 34596747
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Study Investigating Intraoperative Temperature and Postoperative Pain Course Following Gynaecological Laparoscopy
- ClinicalTrials.gov ID
- NCT02781194
- Acronym / sponsor ID
- TePaLa / 13-030
- Conditions
- Intraoperative Temperature, Postoperative Pain, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- 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 aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration > 60 min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair hugger). Second group will be treated with warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Third group will be treated with both, warming blankets and warmed, humidified insufflation. The peri-operative temperature of patients might be higher in patients of the third group with the combination of both treatments. The investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ between groups. Wound infection incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum will be less.
Detailed description
During the first 30 to 40 minutes of anaesthesia, a patient's temperature can drop to below 35.0°C. Reasons for this include loss of the behavioural response to cold and the impairment of thermoregulatory heat-preserving mechanisms under general or regional anaesthesia, anaesthesia-induced peripheral vasodilation, the use of cold dry insufflation gases. For these reasons, institutions employ a range of techniques to prevent hypothermia, including forced air warming (peri-operatively), use of warmed intravenous fluids, temperature monitoring and control of room temperature. Despite these interventions audits demonstrate that 20-56% of patients are hypothermic during the perioperative period. A factor often dismissed as a cause of peri-operative hypothermia during laparoscopic procedures is dry and cold insufflation gas. During laparoscopic procedures the abdomen is continuously insufflated with cold, dry CO2 resulting in desiccation and heat loss which consequently induces hypothermia in the patient. Clinical evidence suggests that the risk of hypothermia can be reduced using warm and humidified gas, as has been shown in animal models, in clinical trials and confirmed in a metaanalysis in humans. Only gas at body temperature and fully saturated with moisture will prevent loss of energy from the peritoneum surface - because it is physically not possible to evaporate fluids into a fully saturated gas. Therefore, the fluid layer will be maintained, minimizing energy loss from the body, decreasing the hypothermia induced by the evaporative losses in laparoscopic surgery and stabilizing the fibrinolytic activity of the peritoneum. The aim of this investigation is to assess the impact of forced air warming, warm humidified insufflation gas and the combination of the two on intraoperative temperature maintenance and the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration > 60 min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair hugger). Second group will be treated with warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. Third group will be treated with both, warming blankets and warmed, humidified insufflation. The peri-operative temperature of patients might be higher in patients of the third group with the combination of both treatments. The investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ between groups. Wound infection incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum will be less.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| forced-air warming blanket | Experimental | Device: 3M™ Bair Hugger™Forced-air warming blanket via 3M™ Bair Hugger™. |
| warmed, humidified insufflation | Experimental | Device: F&P HumiGard™ Surgical Humidification SystemWarmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. |
| forced-air warming blanket & warmed, humidified insufflation | Experimental | Device: 3M™ Bair Hugger™, Device: F&P HumiGard™ Surgical Humidification SystemCombination of forced-air warming blanket via 3M™ Bair Hugger™ and warmed, humidified insufflation via the F\&P HumiGard™ Surgical Humidification System. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or above and aged under 70 years
- Written informed consent prior to study participation
- Patients admitted to hospital for laparoscopic surgery with a planned duration of more than 1 hour; if there is an open component to the surgery then this should be discussed, in terms of the length of the laparoscopic component
- BMI <35
Key exclusion criteria (8 listed)
- Pregnancy or women without sufficient contraception
- Women, who are breastfeeding
- Alcohol or drug abuse
- Expected non-compliance
- Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
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 |
|---|---|---|
| 3M™ Bair Hugger™forced-air warming blanket | Device | forced-air warming blanket, forced-air warming blanket & warmed, humidified insufflation |
| F&P HumiGard™ Surgical Humidification Systemwarmed, humidified insufflation | Device | forced-air warming blanket & warmed, humidified insufflation, warmed, humidified insufflation |
Primary outcome
Intra-operative core temperature
Time frame: 2 hours
Intra-operative core temperature measured via oesophageal probe/urinary catheter after anaesthetic induction (baseline) but before insufflation and at 10 minute intervals until completion of surgery; hypothermia (<36 C) during the peri-operative period to be indicated by: * Mild (core temperature 35.0 °C to 35.9 °C) * Moderate (34.0 °C to 34.9 °C) * Severe ≤33.9 °C)
Body temperature
Time frame: 2 hours
Body temperature as measured by direct tympanic thermometer: * Pre-operatively - 1 hour before induction and at 10 minute intervals until induction * Before anesthetic induction * Post-operatively at entry to recovery room and at 10 minute intervals or until normo-thermia (≥36.5 °c) is achieved. Time at which normothermia is achieved to be recorded.
VAS (visual analouge scale): composite measure of pain in different regions of the body
Time frame: up to 7 days
VAS: Pain from abdominal area - Pain in the shoulder - Pain on movement - Pain on coughing, before transfer to ward; at arrival in recovery room; 8 a.m. + 8 p.m. until discharge; 0 - 10 Numeric Pain Rating Scale by VAS, National Institute of Pain Control - NIPCTM
morphine equivalent daily dose (MEDD) usage in patient controlled analgesia (PCA)
Time frame: up to 7 days
MEDD usage: intraoperative, post anaesthesia care unit (PACU), Day 0, Day 1, Day 2, Day 3, Total during admission, Day on which PCA is removed if PCA is used. Start of PCA to be standardised, if possible all patient requests for PCA to be recorded by software, even if patient lockout has occurred due to too many attempts to activate PCA in a certain time.
Perioperative Fluid (PV)
Time frame: 2 hours
PV to be recorded at 10 min intervals perioperatively. Volume of electrolyte solution infused to be recorded, as well as time from induction until infusion takes place.
Fibrinolytic activity
Time frame: 2 days
Fibrinolytic activity in the peritoneal fluid will be determined at the beginning of surgery and Day 1. Sample will be taken from an abdominal drain.
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 12 Feb 2019.
- Results publication1. Frank S, Fleisher L, Breslow M, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial [see comments]. JAMA 1997; 277(14):1127-34. -- 2. Frank S, Higgins M, Fleisher L, et al. Adrenergic, respiratory, and cardiovascular effects of core cooling in humans. Am J Physiol 1997; 272(2 Pt 2):R557-62. -- 3. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. New England Journal of Medicine 1996; 334(19):1209-1215. -- 4. Hofer CK, Worn M, Tavakoli R, et al. Influence of body core temperature on blood loss and transfusion requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc Surg 2005; 129(4):838-43. -- 5. Johansson T, Lisander B, Ivarsson I. Mild hypothermia does not increase blood loss during total hip arthroplasty. Acta Anaesthesiol Scand 1999; 43(10):1005-10. -- 6. Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial.[see comment][erratum appears in Lancet 2002 Mar 9;359(9309):896]. Lancet 2001; 358(9285):876-80. -- 7. Nesher N, Zisman E, Wolf T, et al. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg 2003; 96(2):328-35, table of contents. -- 8. Persson K, Lundberg J. Perioperative hypothermia and postoperative opioid requirements. Eur J Anaesthesiol 2001; 18(10):679-86. -- 9. Schmied H, Kurz A, Sessler DI, et al. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet 1996; 347(8997):289-92. -- 10. Sellden E. Peri-operative amino acid administration and the metabolic response to surgery. Proc Nutr Soc 2002; 61(3):337-43.
- Derived from this study: PubMed 35286431Wittenborn J, Mathei D, van Waesberghe J, Zeppernick F, Zeppernick M, Tchaikovski S, Kowark A, Breuer M, Keszei A, Stickeler E, Zoremba N, Rossaint R, Bruells C, Meinhold-Heerlein I. The effect of warm and humidified gas insufflation in gynecological laparoscopy on maintenance of body temperature: a prospective randomized controlled multi-arm trial. Arch Gynecol Obstet. 2022 Sep;306(3):753-767. doi: 10.1007/s00404-022-06499-z. Epub 2022 Mar 14.
- Derived from this study: PubMed 34596747Breuer M, Wittenborn J, Rossaint R, Van Waesberghe J, Kowark A, Mathei D, Keszei A, Tchaikovski S, Zeppernick M, Zeppernick F, Stickeler E, Zoremba N, Meinhold-Heerlein I, Bruells C. Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial. Surg Endosc. 2022 Jun;36(6):4154-4170. doi: 10.1007/s00464-021-08742-1. Epub 2021 Oct 1.
- 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.
Julia Wittenborn, Dr. med. principal investigator
Uniklink RWTH Aachen, Klinik für Gynäkologie und Geburtsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Bair Hugger™ and F&P HumiGard™ Surgical Humidification System in people with Intraoperative Temperature and Postoperative Pain, run by RWTH Aachen University at 1 site in Germany.
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 8 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 12 Feb 2019. 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 Germany. 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?
Intra-operative core temperature (time frame: 2 hours). The study lists 6 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 NCT02781194, 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 12 Feb 2019.