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

NCT05426278 | Unknown DMC

• 1 other identifier: 2022-7343-21332
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypothermia; Anesthesia; Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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 1. \- Nausea present , No Vomiting 2. \- Nausea present , Vomiting present 3. \- 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 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

  Day 1

Study Arms (2)

FAW and Bair Hugger Group

OTHER

Group B, the intervention group (with FAW and Bair Hugger).

Device: Bair hugger and Forces air warmer

Control group

NO INTERVENTION

Group A, the control group (No FAW or Bair Hugger)

Interventions

Bair hugger and Forces air warmer DEVICE

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

FAW and Bair Hugger Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Related Publications (4)

• 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.

  PMID: 25837741 BACKGROUND

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

  PMID: 29726859 BACKGROUND

• 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.

  PMID: 18330074 BACKGROUND

• 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.

  PMID: 33053048 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Central Study Contacts

Tashfain Bin Zafar, MBBS

CONTACT

+92 3362459094; tashfain.zafar@aku.edu

Mohammad Hamid, MD

CONTACT

+92 3002412205; mohammad.hamid@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 2 groups will be made - One group will be interventional and the Other will be the Control group

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share