Perioperative Normothermia: Temperature and Prewarming Methods

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04011462
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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	N/A

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 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: Jul 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2021
• Anticipated Study Completion Date: Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICESP	São Paulo		Brazil	05403-000

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanessa de Brito Poveda, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT04011462
• Other Study ID Numbers: VPoveda
• First Posted: Jul 8, 2019
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Professor, University of Sao Paulo: Nursing; Hypothermia; Perioperative Nursing
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Sep 28, 2021