Postoperative Hypothermia Control In Older Patients With Total Knee Arthroplasty: Effect Of Electric And Woolen Blanket

NCT05389579 | Completed

• 1 other identifier: 16969557-964
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this studywas to assess as experimental whether if electric blanket together withwoolen blanketwere effective in the postoperative period at patients with TKA. The population of the studywas the TKA patients operated at Kastamonu State Hospital (N=209); the sample with quota sampling was a total of 46 patients, including 23 selected 23 control group. Data collection forms for data collection, tympanic thermometer, saturation meter, sphygmomanometer, woolen blankets and electric blankets were used in research process.The data collected in this study were analyzed using SPSS 16.0 software. To analyze the data; descriptive statistics, Kolmogorov-Smirnov, X2, Student's t, Mann-Whitney U test, Kruskal-Wallis analysis of variance ANOVA and linear regression analysis were used. According to the results; it was determined that the use of electric blankets together with woolen blankets was an efficient method of warming for TKA patients and unheated woolen blanketsare not sufficient to improve body temperature postoperatively. Studying with large samples and assessing the effectiveness of warmed woolen blankets with determining the number of warmed woolen blanket for enhancing the control of hypothermia is suggested.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Hypothermia; Postoperative period; Woolen blanket; Electric blanket; older people.

Outcome Measures

Primary Outcomes (45)

• preoperative measures-1a

  patients' tympanic temperature °C

  15 minutes before surgery

• preoperative measures-1b

  patients' tympanic heart beat rate/min

  15 minutes before surgery

• preoperative measures-1c

  patients' ventilation rate/min

  15 minutes before surgery

• preoperative measures-1d

  patients' saturation SaO2

  15 minutes before surgery

• preoperative measures-1e

  patients' systolic/daistolic blood pressure mmHg

  15 minutes before surgery

• postoperative measures for 15th minute-2a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 15th minute-2b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 15th minute-2c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 15th minute-2d

  patients' saturation

  within 5 minutes

• postoperative measures for 15th minute-2e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 30th minute-3a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 30th minute-3b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 30th minute-3c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 30th minute-3d

  patients' saturation

  within 5 minutes

• postoperative measures for 30th minute-3e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 45th minute-4a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 45th minute-4b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 45th minute-4c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 45th minute-4d

  patients' saturation

  within 5 minutes

• postoperative measures for 45th minute-4e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 60th minute-5a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 60th minute-5b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 60th minute-5c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 60th minute-5d

  patients' saturation

  within 5 minutes

• postoperative measures for 60th minute-5e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 75th minute-6a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 75th minute-6b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 75th minute-6c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 75th minute-6d

  patients' saturation

  within 5 minutes

• postoperative measures for 75th minute-6e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 90th minute-7a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 90th minute-7b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 90th minute-7c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 90th minute-7d

  patients' saturation

  within 5 minutes

• postoperative measures for 90th minute-7e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 105th minute-8a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 105th minute-8b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 105th minute-8c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 105th minute-8d

  patients' saturation

  within 5 minutes

• postoperative measures for 105th minute-8e

  patients' systolic/diastolic blood pressure

  within 5 minutes

• postoperative measures for 120th minute-9a

  patients' tympanic temperature

  within 5 minutes

• postoperative measures for 120th minute-9b

  patients' heart beat rate

  within 5 minutes

• postoperative measures for 120th minute-9c

  patients' ventilation rate

  within 5 minutes

• postoperative measures for 120th minute-9d

  patients' saturation

  within 5 minutes

• postoperative measures for 120th minute-9e

  patients' systolic/diastolic blood pressure

  within 5 minutes

Secondary Outcomes (1)

• end of measurement

  within 125 minutes

Study Arms (2)

Control Group

NO INTERVENTION

After the patients were taken to their own beds after surgery, the researcher covered them with a wool blanket from the top of clavicle to the bottom of their feet, put the sphygmomanometer on the arm without an IV line, positioned the sphygmomanometer so that the instrument panel was on the blanket and measured blood pressure. the SPO2 probe was put on the patients' fingers after blood pressure measurements and counted respiratory rates for one minute while waiting for the SPO2 measurements. After this measurement, the researcher evaluated shivering by observation, and recorded these data on the DCIF. the temperature and humidity in the room on a thermohygrometer were read and recorded on the evaluation form. Body temperature, pulse rate, respiration rate, arterial blood pressure, pulse pressure, oxygen saturation, feeling cold and shivering were examined both experimental and control group before their surgeries, every 15 minutes after surgeries until being 36 0C.

Intervention Group

EXPERIMENTAL

After the patients were taken to their own beds after surgery, the researcher covered them with a wool blanket from the top of clavicle to the bottom of their feet, put the sphygmomanometer on the arm without an IV line, positioned the sphygmomanometer so that the instrument panel was on the blanket and measured the patients' blood pressure. Then, the electric blanket was operated at the "warm" level for the experimental group, and it was turned off and unplugged when their body temperature reached 36.0 °C.

Device: electric blanket

Interventions

electric blanket DEVICE

After the patients were taken to their own beds after surgery, the researcher covered them with a wool blanket from the top of clavicle to the bottom of their feet, put the sphygmomanometer on the arm without an IV line, positioned the sphygmomanometer so that the instrument panel was on the blanket and measured the patients' blood pressure. Then, the electric blanket was operated at the "warm" level for the experimental group, and it was turned off and unplugged when their body temperature reached 36.0 °C.

Intervention Group

Eligibility Criteria

• Age: 60 Years - 79 Years
• Gender Eligibility Details: AGE GENDER Control group Intervention Group Female Male Female Male 60-69 9 4 9 4 70-79 7 3 7 3
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being between the ages of 60 to 79,
• having an SPO2 value above 90% when they were hospitalized,
• not having diseases affecting cognitive functions or thermoregulation due to systemic effects,
• not using any medication which could effect thermoregulation.

You may not qualify if:

• patients who wished to withdraw from the study since they felt uncomfortable
• because of the clinical interventions, or who had to be taken to the intensive care unit due to the unexpected changes in their general condition.

Sponsors & Collaborators

• Esra Demirarslan: lead

Study Sites (1)

Kastamonu University

Kastamonu, 37200, Turkey (Türkiye)

Location

Related Publications (2)

• Baker B, Lawson R. Maternal and newborn outcomes related to unplanned hypothermia in scheduled low-risk cesarean delivery births. Newborn & Infant Nursıng Revıews. 2012;12(2):75-77.

  BACKGROUND

• Camus Y, Delva E, Bossard AE, Chandon M, Lienhart A. Prevention of hypothermia by cutaneous warming with new electric blankets during abdominal surgery. Br J Anaesth. 1997 Dec;79(6):796-7. doi: 10.1093/bja/79.6.796.

  PMID: 9496215 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fethiye ERDİL, prof

  Retired

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Model Details: As a parallel group, randomized controlled trial with repeated measures to test the following hypothesis: the average body temperature of patients who use an electric blanket along with a woolen blanket reaches a normal value at least one timeframe (15 minutes) before that of patients who use a woolen blanket. It was used electric blankets for the patients in the experimental group in addition to the routine practices in the clinic and did the routine practice in the clinic for the patients in the control group by the researcher.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: May 25, 2022
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: April 8, 2015
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)