Forced Air Warming Effect on HypothermiaPWPSNCT02243462
Preoperative Warming and Perioperative Shivering
A study testing Forced Air Warmer and No pre-op warming in people with Forced Air Warming Effect on Hypothermia, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial summary
Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Forced Air Warming Effect on Hypothermia
- What is being tested?
- Forced Air Warmer and No pre-op warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2014to Jul 2015
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients going under therapeutic laparoscopic surgery
- All patients between 15-70 years irrespective of their gender
- ASA 1-3 patients
- Those who have given informed consent
Who cannot join
- Any patient undergoing diagnostic laparoscopic surgery
- Patients below age of 15 yrs
- ASA 4 or higher patients
- Patients not giving informed consent
Trial locations and contacts
1 site in 1 country.
Asghar Ali, MBBS contact
Naila Baig-Ansari, PhD contact
Pakistan1 site, 1 recruiting
- Recruiting
The Indus Hospital
Karachi, Sindh
Naila Baig-Ansari, PhD, naila.baig.ansari@gmail.com
Rashna Dubash, rashna.dubash@irdresearch.org
About this study
Official title: Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering
Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
Read the detailed description
Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. Although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. It is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. New guidelines recommend that patients core temperature has to be maintained at >36°C, postoperatively. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. They are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices.
Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
- Conditions
- Forced Air Warming Effect on Hypothermia
- Being tested
- Forced Air Warmer, No pre-op warming
- Keywords
- Shivering, Hypothermia, Postoperative, Temperature, Forced air warmer
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Air WarmerDevice
Also called WarmTouch Convective Warming System, Forced air warmer (FAW)
A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable "blanket". The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket.
No pre-op warmingOther
No forced air warming of the patient prior to being taken in for surgery
| Study group | Role | What they receive |
|---|---|---|
| No pre-op warming | Other | No pre-warming in bay before surgery. Receives: Other: No pre-op warming |
| Pre-op forced air warming | Active comparator | A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery Receives: Device: Forced Air Warmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
inadvertent shivering post surgery
number of patients who experience shivering in holding bay
Measured: upto 2-3 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forced Air Warming Effect on 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Asgher, Indus Hospital and Health Network
- Investigators
- Ali Asghar, MBBS, Principal investigator, The Indus HospitalShahid Amin, Study director, The Indus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243462
- Sponsor's protocol ID
- TIH-Anesth-001
- Other IDs
- IRD_IRB_2014_06_003
- Acronym
- PWPS
- Status last verified
- Apr 2015
- First submitted
- 14 Sep 2014
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering
- ClinicalTrials.gov ID
- NCT02243462
- Acronym / sponsor ID
- PWPS / TIH-Anesth-001
- Conditions
- Forced Air Warming Effect on Hypothermia
- Keywords
- Shivering, Hypothermia, Postoperative, Temperature, Forced air warmer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 18 Sep 2014 (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.
Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
Detailed description
Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. Although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. It is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. New guidelines recommend that patients core temperature has to be maintained at >36°C, postoperatively. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. They are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices.
Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No pre-op warming | Other | Other: No pre-op warmingNo pre-warming in bay before surgery. |
| Pre-op forced air warming | Active comparator | Device: Forced Air WarmerA forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients going under therapeutic laparoscopic surgery
- All patients between 15-70 years irrespective of their gender
- ASA 1-3 patients
- Those who have given informed consent
Key exclusion criteria (4 listed)
- Any patient undergoing diagnostic laparoscopic surgery
- Patients below age of 15 yrs
- ASA 4 or higher patients
- Patients not giving informed consent
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 WarmerAlso: WarmTouch Convective Warming System, Forced air warmer (FAW)A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable "blanket". The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket. | Device | Pre-op forced air warming |
| No pre-op warmingNo forced air warming of the patient prior to being taken in for surgery | Other | No pre-op warming |
Primary outcome
inadvertent shivering post surgery
Time frame: upto 2-3 hours post-surgery
number of patients who experience shivering in holding bay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Asghar Ali, MBBS contact
Naila Baig-Ansari, PhD contact
Ali Asghar, MBBS principal investigator
The Indus Hospital
Shahid Amin study director
The Indus 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 Warmer and No pre-op warming in people with Forced Air Warming Effect on Hypothermia, run by Indus Hospital and Health Network at 1 site in Pakistan.
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 4 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 15 Apr 2015. 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 Pakistan. 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?
Contact Asghar Ali, MBBS (aliasgherkika@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inadvertent shivering post surgery (time frame: upto 2-3 hours post-surgery). 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 15 Apr 2015.