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临床试验/NCT05762081
NCT05762081Enrolling By Invitation不适用

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 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
2
主要终点
Change in Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change in Blood Pressure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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).

时间窗: Baseline and immediately after bathing, 30 minutes after bathing

Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sercan Kara

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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