Hypothermia; AnesthesiaNCT05426278
The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
A study testing Bair hugger and Forces air warmer in people with Hypothermia; Anesthesia and Nausea and Vomiting, Postoperative, run by Aga Khan University.
Trial summary
Intraoperative Hypothermia is a common problem, our object will be to evaluate the efficacy of forced air warmer (Model # eq-5000) for maintaining core body temperature in patients undergoing laparoscopic surgeries and its effect on postoperative nausea, vomiting and shivering. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia, Nausea and Vomiting, Postoperative
- What is being tested?
- Bair hugger and Forces air warmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic surgeries (Hernia Repair, Cholecystectomy, Appendectomy, Hysterectomy)
- ASA Category I and II as per American Society of Anaesthesiologist Classification.
- BMI< 35 kg/m2
- Duration of surgery >1 hour and <3 hours
- Patients who consent their participation
Who cannot join
- Temperature >37.5oC or <35oC,
- Chronic kidney disease
- Heart failure
- ASA Category 3\&4 (American Society of Anaesthesiologist Classification)
- Patients will be withdrawn from the group if their laparoscopy is converted to open surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
Intraoperative Hypothermia is a common problem, our object will be to evaluate the efficacy of forced air warmer (Model # eq-5000) for maintaining core body temperature in patients undergoing laparoscopic surgeries and its effect on postoperative nausea, vomiting and shivering.
- Being tested
- Bair hugger and Forces air warmer
- Medical subject headings
- Hypothermia, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair hugger and Forces air warmerDevice
The EQUATOR™ (EQ-5000) air-warmer is a convective warmer, with the average and maximum Contact Surface Temperatures of 39℃ \& 44℃ Respectively. Temperature on this device can be set at 36℃ , 40℃ , 44℃. The 3M™ Bair Hugger ™ (SW-2003) upper body blanket is used to warm the body from head till the xiphisternum
| Study group | Role | What they receive |
|---|---|---|
| FAW and Bair Hugger Group | Other | Group B, the intervention group (with FAW and Bair Hugger). Receives: Device: Bair hugger and Forces air warmer |
| Control group | No intervention | Group A, the control group (No FAW or Bair Hugger) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Nausea Vomiting Scale
The scores of 0-3 will determine severity on the Post-operative nausea and vomiting scale.
0 - No nausea , No vomiting
- - Nausea present , No Vomiting
- - Nausea present , Vomiting present
- - Vomiting >2 episodes within 30 minutes
Measured: Day 1
Bedside Shivering Assessment Scale (BSAS)
The scores of 0-3 will determine severity on Shivering
0 -(none) No shivering is detected on palpation of masseter, Neck, or chest muscles
- -(mild) Shivering localized to Neck and thorax only
- -(moderate) Shivering involves gross movement of the upper extremities( in addition to neck and thorax)
- -(severe) Shivering involves gross movements of the trunk and upper and lower extremities
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
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; 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
- Model description
- 2 groups will be made - One group will be interventional and the Other will be the Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hamid, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426278
- Sponsor's protocol ID
- 2022-7343-21332
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
PubMed 25837741Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
PubMed 29726859Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
PubMed 18330074Liang D, Shan Y, Wang L. The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study. Sao Paulo Med J. 2020 Sep-Oct;138(5):414-421. doi: 10.1590/1516-3180.2020.0059.R2.06072020.
PubMed 33053048
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05426278
- Acronym / sponsor ID
- 2022-7343-21332
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Jun 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.
Intraoperative Hypothermia is a common problem, our object will be to evaluate the efficacy of forced air warmer (Model # eq-5000) for maintaining core body temperature in patients undergoing laparoscopic surgeries and its effect on postoperative nausea, vomiting and shivering.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups will be made - One group will be interventional and the Other will be the Control group
| Arm | Type | Receives |
|---|---|---|
| FAW and Bair Hugger Group | Other | Device: Bair hugger and Forces air warmerGroup B, the intervention group (with FAW and Bair Hugger). |
| Control group | No intervention | –Group A, the control group (No FAW or Bair Hugger) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing laparoscopic surgeries (Hernia Repair, Cholecystectomy, Appendectomy, Hysterectomy)
- ASA Category I and II as per American Society of Anaesthesiologist Classification.
- BMI< 35 kg/m2
- Duration of surgery >1 hour and <3 hours
- Patients who consent their participation
Key exclusion criteria (5 listed)
- Temperature >37.5oC or <35oC,
- Chronic kidney disease
- Heart failure
- ASA Category 3\&4 (American Society of Anaesthesiologist Classification)
- Patients will be withdrawn from the group if their laparoscopy is converted to open 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 |
|---|---|---|
| Bair hugger and Forces air warmerThe EQUATOR™ (EQ-5000) air-warmer is a convective warmer, with the average and maximum Contact Surface Temperatures of 39℃ \& 44℃ Respectively. Temperature on this device can be set at 36℃ , 40℃ , 44℃. The 3M™ Bair Hugger ™ (SW-2003) upper body blanket is used to warm the body from head till the xiphisternum | Device | FAW and Bair Hugger Group |
Primary outcome
Post Operative Nausea Vomiting Scale
Time frame: Day 1
The scores of 0-3 will determine severity on the Post-operative nausea and vomiting scale. 0 - No nausea , No vomiting 1. - Nausea present , No Vomiting 2. - Nausea present , Vomiting present 3. - Vomiting >2 episodes within 30 minutes
Bedside Shivering Assessment Scale (BSAS)
Time frame: Day 1
The scores of 0-3 will determine severity on Shivering 0 -(none) No shivering is detected on palpation of masseter, Neck, or chest muscles 1. -(mild) Shivering localized to Neck and thorax only 2. -(moderate) Shivering involves gross movement of the upper extremities( in addition to neck and thorax) 3. -(severe) Shivering involves gross movements of the trunk and upper and lower extremities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Background: PubMed 25837741Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
- Background: PubMed 29726859Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
- Background: PubMed 18330074Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
- Background: PubMed 33053048Liang D, Shan Y, Wang L. The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study. Sao Paulo Med J. 2020 Sep-Oct;138(5):414-421. doi: 10.1590/1516-3180.2020.0059.R2.06072020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Bair hugger and Forces air warmer in people with Hypothermia; Anesthesia and Nausea and Vomiting, Postoperative, run by Aga Khan University.
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 5 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tashfain Bin Zafar, MBBS (+92 3362459094, tashfain.zafar@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Nausea Vomiting Scale (time frame: Day 1). The study lists 2 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 NCT05426278, 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 21 Jun 2022.