The Effect of Two Different Bed Baths Applied to Patients on Mechanical Ventilation Support

February 27, 2023 updated by: Sercan Kara, Istanbul University - Cerrahpasa (IUC)

The Effect of Two Different Bed Baths Applied to Patients on Mechanical Ventilation Support on Vital Signs: A Randomized Controlled Trial

The aim of this study was to determine the effect of two different methods (traditional bed bathing and disposable antibacterial wipe bathing) on vital signs in patients on mechanical ventilation support.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study is planned as a randomized controlled study to determine the effect of the performance of two types of bed (bed-traditional and disposable antibacterial wipe bath) on respiratory parameters and vital signs in adult patients with different clinical conditions connected to mechanical ventilation. At the end of the study, it is aimed to evaluate the effect of traditional and disposable antibacterial wiping baths on vital signs in patients on mechanical ventilation support.

Relatives of the patients who meet the inclusion criteria will be informed about the purpose, content and method of the study and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. Determination of the experimental and control groups will be provided by https://www.randomizer.org/ website. The wiping bath protocol with disposable antibacterial wipes will be applied to the experimental group in accordance with the literature, and the traditional bed bath protocol will be applied to the patients in the control group by the researcher himself. Patient Information Form containing information about the demographic characteristics and medical status of the patients included in the study; vital signs (pulse, systolic and diastolic blood pressure, body temperature, respiratory rate and SpO2) and blood gas data will be recorded 3 times in total (before the bath - current blood gas value, immediately after the bath - morning routine blood gas, 30 minutes or more after the bath - the first blood gas taken with the physician's order) based on the values in the routine blood gas measurements of the clinic, partial arterial oxygen and partial arterial carbon dioxide parameters will be recorded in the vital signs follow-up form. All data collection tools will be completed by the researcher himself.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Sercan KARA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older, whose voluntary consent is obtained from a relative or legal guardian,
  • Dependent on mechanical ventilation,
  • Not receiving antihypertensive and sedation therapy,
  • Not taking inotropic drugs that directly affect vital signs (esmolol, noradrenaline dopamine, adrenaline, dopamine nitrate, etc.),
  • No wound that prevents bathing,
  • Moving it does not cause any problems,
  • Minimum 24 hours in intensive care,
  • Patients with blood gas readings taken 30 minutes or more after bathing

Exclusion Criteria:

  • Not dependent on mechanical ventilation,
  • Receiving antihypertensive and sedation therapy,
  • Taking inotropic drugs that directly affect vital signs (esmolol, noradrenaline dopamine, adrenaline, dopamine nitrate, etc.),
  • A person with a wound that prevents bathing,
  • It is important to note that moving it does not cause any problems,
  • Less than 24 hours in intensive care,
  • Patients in whom blood gas readings were not taken 30 minutes or more after bathing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Individuals who have undergone wiping bathing with disposable wipes
Procedure: Disposable Wipes for wiping baths
A disposable wipe bath is a type of bath that is applied to bed-bound or unconscious patients and weak individuals by wiping the entire body.
Sham Comparator: Control Group
Individualswho have undergone bathing with a traditional bath
Procedure: Traditional bed bath
Traditional bed bathing is a type of bathing applied to bed-bound or unconscious patients and weak individuals by wiping the entire body with soap and water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Blood pressure will be measured on the patient monitor. Results will be reported in mmHg.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Pulse Rate
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Pulse rate will be measured on the patient monitor. The results presented as beat per minute.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Respiratory Rate
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Respiratory rate will be measured on the patient monitor. Higher scores mean a worse result.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Body Temperature
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
A calibrated non-contact infrared thermometer will be used to measure body temperature. Results will be reported in Celcius.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Oxygen Saturation
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Oxygen Saturation will be measured on the patient monitor. Approaching %100 is concidered positive. Higher scores mean a better result.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).
Baseline and immediately after bathing, 30 minutes after bathing
Change in Mechanical Ventilation Mode
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
The patient's mechanical ventilation mode will be observed. SIMV, CBAP, etc.
Baseline and immediately after bathing, 30 minutes after bathing
Change in Partial Oxygen Pressure (PaO2)
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis
Baseline and immediately after bathing, 30 minutes after bathing
Change in Partial Carbon Dioxide Pressure
Time Frame: Baseline and immediately after bathing, 30 minutes after bathing
Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Baseline and immediately after bathing, 30 minutes after bathing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Anticipated)

August 15, 2023

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-282

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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