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Preoperative Warming and Perioperative Shivering (PWPS)

I

Indus Hospital and Health Network

Status

Unknown

Conditions

Forced Air Warming Effect on Hypothermia

Treatments

Device: Forced Air Warmer
Other: No pre-op warming

Study type

Interventional

Funder types

Other

Identifiers

NCT02243462
IRD_IRB_2014_06_003 (Other Identifier)
TIH-Anesth-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Any patient undergoing diagnostic laparoscopic surgery
  • Patients below age of 15 yrs
  • ASA 4 or higher patients
  • Patients not giving informed consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

180 participants in 2 patient groups

No pre-op warming
Other group
Description:
No pre-warming in bay before surgery.
Treatment:
Other: No pre-op warming
Pre-op forced air warming
Active Comparator group
Description:
A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery
Treatment:
Device: Forced Air Warmer

Trial contacts and locations

1

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Central trial contact

Naila Baig-Ansari, PhD; Asghar Ali, MBBS

Data sourced from clinicaltrials.gov

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