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Clinical Trials/NCT05762081
NCT05762081Enrolling By InvitationNot Applicable

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

Istanbul University - Cerrahpasa (IUC)2 sites in 1 country100 target enrollmentStarted: February 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Change in Blood Pressure

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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

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)

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.

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sercan Kara

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Study Sites (2)

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