The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

NCT ID: NCT03824262

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2019-05-04

Brief Summary

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The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

Detailed Description

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The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

Conditions

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Temperature Change, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I

HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device

Group Type EXPERIMENTAL

HICO-VARIOTHERM 550

Intervention Type DEVICE

Warming during perioperative period.

Mistral-Air Plus forced air warming device

Intervention Type DEVICE

Warming during perioperative period.

Group II

Mistral-Air Plus forced-air warming device

Group Type ACTIVE_COMPARATOR

Mistral-Air Plus forced air warming device

Intervention Type DEVICE

Warming during perioperative period.

Interventions

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HICO-VARIOTHERM 550

Warming during perioperative period.

Intervention Type DEVICE

Mistral-Air Plus forced air warming device

Warming during perioperative period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Major abdominal surgery in litotomy position
* ASA I-II
* Anticipated operation time over 1 hour

Exclusion Criteria

* Sepsis
* Hypothermia
* Hyperthermia
* Malignant Hyperthermia
* Tyroid dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Filiz Uzumcugil

Principal Investigator, MD, Asist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meral Kanbak, Prof

Role: STUDY_CHAIR

Hacettepe University

FİLİZ UZUMCUGIL

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University School of Medicine Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E.308215

Identifier Type: -

Identifier Source: org_study_id

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