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Perioperative Normothermia: Temperature and Prewarming Methods (Normothermia)

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ClinicalTrials.gov Identifier: NCT04011462
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Vanessa de Brito Poveda, University of Sao Paulo

Brief Summary:
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

Condition or disease Intervention/treatment Phase
Hypothermia Device: prewarming 20 minutes Device: prewarming 30 minutes Not Applicable

Detailed Description:
The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Perioperative Normothermia: Temperature and Prewarming Methods
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Prewarming 20 minutes
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.
Device: prewarming 20 minutes
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.

Experimental: Prewarming 30 minutes
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.
Device: prewarming 30 minutes
prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.

No Intervention: Standard care
warming with cotton sheet and blanket for 20 minutes.



Primary Outcome Measures :
  1. Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer [ Time Frame: Perioperative period ]
    Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to number of patients with temperature below 36 degrees measured by the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years and over at the time of data collection
  • Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour

Exclusion Criteria:

  • Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
  • Patients submitted to video laparoscopic or minimally invasive surgeries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011462


Contacts
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Contact: Vanessa de Brito Poveda, PhD 55 11 30618837 vbpoveda@usp.br

Locations
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Brazil
ICESP Recruiting
São Paulo, Brazil, 05403-000
Contact: Vanessa Poveda, Ph.D.    551130618837    vbpoveda@usp.br   
Contact: Joao Possari, Ph.D.    551130618837    joao.possari@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo
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Responsible Party: Vanessa de Brito Poveda, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04011462    
Other Study ID Numbers: VPoveda
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanessa de Brito Poveda, University of Sao Paulo:
Nursing
Hypothermia
Perioperative Nursing
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms