Shivering_Basel_Baden

Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial

Shivering is known to occur in around 40% of women as a side effect of neuraxial anaesthesia during caesarean section.Women undergoing caesarean section under neuraxial anaesthesia are randomised into either the treatment group or control group. Women in both groups are observed during caesarean section. This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering.

Study Overview

• Status: Recruiting
• Conditions: Shivering
• Intervention / Treatment: Other: Gloves filled with warm tap water

Detailed Description

Shivering is an involuntary, repetitive activity of skeletal muscles that often, but not exclusively, occurs as a thermoregulatory response to cold. It is associated with neuraxial anaesthesia and is therefore a commonly observed phenomenon during caesarean sections. The main cause for this is a sympathetic block of vasoconstriction in the legs, leading to cutaneous heat loss and lower core temperature. This is not always accompanied by a cold sensation, because the perceived skin temperature is increased. Out of all common side effects of neuraxial anaesthesia, shivering is perceived as the most uncomfortable and disruptive one. It can also interfere with monitoring of blood pressure, oxygen saturation and legibility of electrocardiograms. It increases the metabolic rate and oxygen consumption by up to 400%. Therefore, lactic acid and carbon dioxide production are significantly increased. Pregnant women have reduced cardiac and pulmonary reserves and may therefore have less capacity to adapt to the increased metabolic demands caused by shivering.

The incidence of shivering during caesarean section at the University Hospital Basel was determined by a previous study to be 41.0%. Studies have been conducted about pharmacological treatment options for intraoperative shivering during caesarean section. However, pharmacological treatment in pregnant and breastfeeding women is best reduced to a minimum.

This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering. The warm water method has been used by doctors to reduce shivering, but the actual effects of it have never been scientifically proven. The gloves will be used as a treatment, not a prophylactic measure. Therefore, only the women who exhibit shivering during surgery will be treated.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bigna Buddeberg, MD; Phone Number: +41 61 328 6417; Email: bigna.buddeberg@usb.ch
• Study Contact Backup: Name: Melanie Dussy +41 76 422 6774; Phone Number: +41 76 422 6774; Email: melanie.dussy@hispeed.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel; Department of Anaesthesiology
    • Contact: Bigna Buddeberg, MD; Phone Number: +41 61 328 6417; Email: bigna.buddeberg@usb.ch
    • Contact: Melanie Dussy; Phone Number: +41 76 422 6774; Email: melanie.dussy@hispeed.ch
    • Principal Investigator: Bigna Buddeberg, MD
  • Aargau
    • Baden, Aargau, Switzerland, 5404
      • Recruiting
      • Kantonsspital Baden AG, Department of Anaesthesiology
      • Contact: Michael Heesen, Prof.; Phone Number: +41 56 486 3102; Email: michael.heesen@ksb.ch
      • Contact: Thierry Girard, Prof.; Phone Number: +41 61 328 6460; Email: thierry.girard@usb.ch
      • Principal Investigator: Michael Heesen, Prof.
      • Sub-Investigator: Thierry Girard, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Ability to give informed consent
• Age older than 18 years and younger than 40 years.
• Gestational age >36 weeks
• Shivering during regional anaesthesia for caesarean section

Exclusion Criteria:

• Inability to give informed consent
• Latex allergy
• Receiving combined spinal epidural anaesthesia (CSEA)
• Secondary spinal anaesthesia for caesarean section in patients with unsatisfactory epidural labour analgesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shivering Treatment Group; Participants will be observed, and intervention will begin when a shivering score of 2 or higher is reached. The participants in the treatment group will receive one glove filled with warm water into each hand.	Other: Gloves filled with warm tap water; The intervention in the treatment group will consist of nonsterile gloves, filled with regular tap water at a comfortable warm temperature and sealed with a plastic clip. The temperature of the water will not be measured, the investigators will take a temperature that feels comfortable in their hands
No Intervention: Control Group; Participants in the control group will only be observed, and not given additional treatment for the shivering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intensity of shivering measured on a 5-point scale	Shivering is evaluated during caesarean section 5 minutes after intervention. Shivering is graded on a scale from 0 (No shivering) to 4 (Violent muscular activity that involves the entire upper body) .The score will be recorded before the intervention and at 2 and 5 minutes after initiation of the intervention, as well as after arrival at the recovery area. Score: 0 - No shivering.; - No visible muscle activity, but one or more of piloerection, peripheral vasoconstriction or peripheral cyanosis (other causes excluded).; - Muscular activity in only one muscle group.; - Moderate muscular activity in more than one muscle group, but not generalized shaking.; - Violent muscular activity that involves the entire upper body.	at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)ent.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective comfort levels of the patients before and after the intervention on a 11-point scale	Change in subjective comfort level of the participant before and after the intervention on a 11-point scale (0 being very uncomfortable; 10 being very comfortable). The patient will be asked to rate their comfort level every time a shivering score is obtained.	at baseline, at 2 and 5 minutes after the first assessment, and in the post-anaesthesia recovery room (approx.1 hour)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Bigna Buddeberg, MD, University Hospital, Basel, Switzerland

Publications and helpful links

Helpful Links

• Paper

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: caesarean section; intraoperative shivering; neuraxial anaesthesia
• Other Study ID Numbers: 2021-00866; qu20Buddeberg

Plan for Individual participant data (IPD)

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

IPD Plan Description

Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study. On the eCRFs and other study specific documents, participants are only identified by a unique participant number.

Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study. On the eCRFs and other study specific documents, participants are only identified by a unique participant number.

The participant identification list will be stored in a locked place by the sponsor-investigator. Password access to the eCRFs will only be given to the investigators directly enrolled in recruitment of participants and capturing of data.

Drug and device information, study documents

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