The Comparison of Warming Techniques in Patients Undergoi... | NCT03824262

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

NCT03824262

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Temperature Change, Body

Interventions

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

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2019Actual

Primary Completion Date

May 4, 2019Actual

Completion Date

May 4, 2019Actual

First Submitted Date

Jan 29, 2019

First Submission Date that Met QC Criteria

Jan 29, 2019

First Posted Date

Jan 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2019

Last Update Posted Date

May 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Filiz Uzumcugil, Principal Investigator, MD, Asist. Prof., Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Experimental	HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device	Device: HICO-VARIOTHERM 550 Device: Mistral-Air Plus forced air warming device
Group II	Active Comparator	Mistral-Air Plus forced-air warming device	Device: Mistral-Air Plus forced air warming device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HICO-VARIOTHERM 550	Device	Warming during perioperative period.	Group I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body temperature-esophageal probe	Esophageal probe used to measure core body temperature	Perioperative period-every 15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Body temperature-tympanic thermometer	Tympanic thermometer used to measure body temperature	Perioperative period-every 15 minutes
Body temperature-skin thermometer	Skin thermometer used to measure body temperature

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meral Kanbak, Prof	Hacettepe University	Study Chair
FİLİZ UZUMCUGIL	Hacettepe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University School of Medicine Hospital		Ankara		06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001832	Body Temperature Changes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

Not provided