NCT04410068

Brief Summary

Compare core body temperature after laparoscopic surgery using the forced air heating system versus the WARMTAC® (a carbon fiber electric blanket).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

May 18, 2020

Last Update Submit

October 5, 2021

Conditions

Temperature Change, BodyHypothermia; Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Core body temperature

    temperatured recorded in esophagus

    through study completion, an average of 12 months

Secondary Outcomes (2)

  • Rescues number

    through study completion, an average of 12 months

  • skin lesions

    through study completion, an average of 12 months

Study Arms (2)

Electrical heating pad

EXPERIMENTAL

Electrical heating pad (WARMTAC device). Patients will be randomized to one arm. In this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down.

Device: WARMTAC

forced-air warming device

EXPERIMENTAL

Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down.

Device: 3M Bair Hugger

Interventions

WARMTACDEVICE

Randomization to one of the arms previous to surgery.

Electrical heating pad
3M Bair HuggerDEVICE

Randomization to one of the arms previous to surgery.

forced-air warming device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age at the time of the preoperative visit.
  • Patients who will undergo elective laparoscopic surgery
  • Patients who sign the informed consent indicating that they have been informed of all relevant aspects of the trial.

You may not qualify if:

  • Axillary temperature\> 37.5ºC
  • Active infection
  • Dysfunction of the autonomic system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08029, Spain

RECRUITING

Related Publications (4)

  • Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish.

    PMID: 30447894BACKGROUND

  • Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.

    PMID: 12697600BACKGROUND

  • Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x.

    PMID: 17042850BACKGROUND

  • John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.

    PMID: 26787794BACKGROUND

MeSH Terms

Conditions

Body Temperature ChangesHypothermia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mireia Chanza, Physician

    PSMar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirea Chanza

CONTACT

0034667550215mchanza@parcdesalutmar.cat

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
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 1, 2020

Study Start

December 23, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 6, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)