NCT04996407

Brief Summary

This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

August 9, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 13, 2021

Last Update Submit

July 30, 2021

Conditions

Hypothermia; Anesthesia

Keywords

perioperative hypothermiageriatricsurvival thermal blanketdraping fabric

Outcome Measures

Primary Outcomes (3)

  • Number of participants with hypothermia in survival thermal blanket group

    Measure by nasopharyngeal thermometer

    Before induction

  • Number of participants with hypothermia in survival thermal blanket group

    Measure by nasopharyngeal thermometer

    every 15 minute during anesthesia

  • Number of participants with hypothermia in survival thermal blanket group

    Measure by nasopharyngeal thermometer

    end of surgery

Secondary Outcomes (3)

  • Number of participants with hypothermia in draping fabric group

    Before induction

  • Number of participants with hypothermia in draping fabric group

    every 15 minute during anesthesia

  • Number of participants with hypothermia in draping fabric group

    end of surgery

Study Arms (2)

survival thermal blanket

ACTIVE COMPARATOR

Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia

Device: survival thermal blanketDevice: draping fabric

draping fabric

ACTIVE COMPARATOR

Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia

Device: survival thermal blanketDevice: draping fabric

Interventions

survival thermal blanketDEVICE

patients were given a thermal blanket

draping fabricsurvival thermal blanket
draping fabricDEVICE

Patients were given a draping fabric

draping fabricsurvival thermal blanket

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 60 years old
  • Physical status ASA 1-3
  • Undergo elective surgery under general anesthesia with or without regional anesthesia

You may not qualify if:

  • Thermoregulation disturbance
  • Abnormal thyroid function
  • Fever caused by infectious disease in 7 days prior to surgery
  • Pre-induction hypothermia with temperature below 36 degree
  • On routine antipiretic
  • Unstable hemodynamic preoperative and intraoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 13, 2021

First Posted

August 9, 2021

Study Start

March 5, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

August 9, 2021

Record last verified: 2021-07

Locations

ID(1)