The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypothermia; Anesthesia; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Device: Bair hugger and Forces air warmer

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tashfain Bin Zafar, MBBS; Phone Number: +92 3362459094; Email: tashfain.zafar@aku.edu
• Study Contact Backup: Name: Mohammad Hamid, MD; Phone Number: +92 3002412205; Email: mohammad.hamid@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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• Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FAW and Bair Hugger Group; Group B, the intervention group (with FAW and Bair Hugger).	Device: Bair hugger and Forces air warmer; 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
No Intervention: Control group; Group A, the control group (No FAW or Bair Hugger)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General 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.
• Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
• Putzu 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.
• Liang 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Body Temperature Changes; Nausea; Vomiting; Hypothermia; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2022-7343-21332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No