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

Primary Purpose

Hypothermia; Anesthesia, Nausea and Vomiting, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bair hugger and Forces air warmer
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    FAW and Bair Hugger Group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2022
    Last Updated
    June 16, 2022
    Sponsor
    Aga Khan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05426278
    Brief Title
    The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
    Official Title
    The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia; Anesthesia, Nausea and Vomiting, Postoperative

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 groups will be made - One group will be interventional and the Other will be the Control group
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FAW and Bair Hugger Group
    Arm Type
    Other
    Arm Description
    Group B, the intervention group (with FAW and Bair Hugger).
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Group A, the control group (No FAW or Bair Hugger)
    Intervention Type
    Device
    Intervention Name(s)
    Bair hugger and Forces air warmer
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Post Operative Nausea Vomiting Scale
    Description
    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
    Time Frame
    Day 1
    Title
    Bedside Shivering Assessment Scale (BSAS)
    Description
    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
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tashfain Bin Zafar, MBBS
    Phone
    +92 3362459094
    Email
    tashfain.zafar@aku.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Hamid, MD
    Phone
    +92 3002412205
    Email
    mohammad.hamid@aku.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25837741
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29726859
    Citation
    Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
    Results Reference
    background
    PubMed Identifier
    18330074
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33053048
    Citation
    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.
    Results Reference
    background

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

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