NCT03824262

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

January 29, 2019

Last Update Submit

May 4, 2019

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

  • Body temperature-esophageal probe

    Esophageal probe used to measure core body temperature

    Perioperative period-every 15 minutes

Secondary Outcomes (6)

  • Body temperature-tympanic thermometer

    Perioperative period-every 15 minutes

  • Body temperature-skin thermometer

    Perioperative period-every 15 minutes

  • Duration of operation

    Perioperative period

  • Blood loss

    Perioperative period

  • Shivering after the operation

    Postoperative 1st hour every 10 minutes

  • +1 more secondary outcomes

Study Arms (2)

Group I

EXPERIMENTAL

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

Device: HICO-VARIOTHERM 550Device: 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

HICO-VARIOTHERM 550DEVICE

Warming during perioperative period.

Group I
Mistral-Air Plus forced air warming deviceDEVICE

Warming during perioperative period.

Group IGroup II

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Sepsis
  • Hypothermia
  • Hyperthermia
  • Malignant Hyperthermia
  • Tyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University School of Medicine Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meral Kanbak, Prof

    Hacettepe University

    STUDY CHAIR

  • FİLİZ UZUMCUGIL

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, Asist. Prof.

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

February 4, 2019

Primary Completion

May 4, 2019

Study Completion

May 4, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)