CClinicalTrials.gg
Status unknownNCT05762081Updated Mar 9, 2023

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

An interventional study of Disposable Wipes for wiping baths and Traditional bed bath in The Effect of Two Different Bed Baths and Patients on Mechanical Ventilation Support, sponsored by Istanbul University - Cerrahpasa. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Nursing
  • Mechanical Ventilation
  • Baths
  • Vital Sings
03

In context

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Individuals who have undergone wiping bathing with disposable wipes

    Procedure: Disposable Wipes for wiping baths

  • Sham comparator
    Control Group

    Individualswho have undergone bathing with a traditional bath

    Procedure: Traditional bed bath

Interventions

  • ProcedureDisposable 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.

  • ProcedureTraditional 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.

06

What researchers measure

Primary outcomes

  1. Change in Blood Pressure

    Blood pressure will be measured on the patient monitor. Results will be reported in mmHg.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  2. Change in Pulse Rate

    Pulse rate will be measured on the patient monitor. The results presented as beat per minute.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  3. Change in Respiratory Rate

    Respiratory rate will be measured on the patient monitor. Higher scores mean a worse result.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  4. Change in Body Temperature

    A calibrated non-contact infrared thermometer will be used to measure body temperature. Results will be reported in Celcius.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  5. Change in Oxygen Saturation

    Oxygen Saturation will be measured on the patient monitor. Approaching %100 is concidered positive. Higher scores mean a better result.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

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

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

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  7. Change in Mechanical Ventilation Mode

    The patient's mechanical ventilation mode will be observed. SIMV, CBAP, etc.

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  8. Change in Partial Oxygen Pressure (PaO2)

    The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

  9. Change in Partial Carbon Dioxide Pressure

    Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

    Time frame: Baseline and immediately after bathing, 30 minutes after bathing

07

Study locations

1 site
  • Sercan KARA
    Istanbul, 34000, Turkey
08

References and documents

Publications

  • Aydın, A. (2011). Kişisel Hijyen ve Yatak Yapımı. İçinde T. Aştı ve A. Karadağ (Ed.). Klinik Uygulama Becerileri ve Yöntemleri. Adana: Nobel Tıp Kitabevi; (375-462).
  • Coyer FM, O'Sullivan J, Cadman N. The provision of patient personal hygiene in the intensive care unit: a descriptive exploratory study of bed-bathing practice. Aust Crit Care. 2011 Aug;24(3):198-209. doi: 10.1016/j.aucc.2010.08.001. Epub 2010 Sep 15. PubMed 20829060 ↗
  • EI-Soussi AH, Asfour Hl.( 2016). Examining bed-bath practices ofcritically ill patients. J Nurs Educ Practice .;( 12):1-11. doi : https: / /doi.org/10 .5430/ jnep.v6n12pl.
  • Garrido D, Assioun JJ, Keshishyan A, Sanchez-Gonzalez MA, Goubran B. Respiratory Rate Variability as a Prognostic Factor in Hospitalized Patients Transferred to the Intensive Care Unit. Cureus. 2018 Jan 23;10(1):e2100. doi: 10.7759/cureus.2100. PubMed 29581913 ↗
  • Groven FM, Zwakhalen SM, Odekerken-Schroder G, Joosten EJ, Hamers JP. How does washing without water perform compared to the traditional bed bath: a systematic review. BMC Geriatr. 2017 Jan 25;17(1):31. doi: 10.1186/s12877-017-0425-4. PubMed 28118815 ↗
  • Kızıl, H.(2015). Mekanik Ventilasyonda Olan Entübe Çocuklara Uygulanan Yatak Banyosunun Yaşam Bulgularına Ve Oksijen Satürasyonuna Etkileri. Yüksek Lisans Tezi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü. İstanbul
  • Moller G, Magalhaes AMM (2015). Bed baths: nursing staff workload and patient safety. Texto Contexto Enferm.;24(4) :1044-52. doi : http ://d x .doi. org/10.1590/ 0104-0707201500003110014.
  • Oz O, Uysal G, Duzkaya DS. Effect of Two Bathing Methods on Physiologic Parameters in Pediatric Intensive Care. Clin Nurs Res. 2022 Jun;31(5):858-865. doi: 10.1177/10547738211043337. Epub 2021 Sep 18. PubMed 34538125 ↗
  • Paulela DC, Bocchi SC, Mondelli AL, Martin LC, Regina A.(2018) Sobrinho. Effecti veness of bag bath on microbial load: clinical trial. Acta Paul Enferm . ;31(1) :7-16. doi: http://dx.doi.org/10.1590/1982-0194201800003
  • Quiroz S, Castro C, Tirado AF, Rodriguez LM . (2012)Alteraciones hemodinamicas del paciente critico card iovascular durante larealizaci6n del bafio diario. Medicina UPB. https://redib.org/Record/oai_articulo1202311- modelo-de-adaptaci%C3%B3n-de-roy-en-el-ba%C3%B1o-en-cama erişim:04.06.2022
  • Silva LF, Miranda AFA, Silva FVF, Rabelo ACS, Almeida PC, Ponte KMA. (2014) Vital signs and nursing procedures in postoperative period of cardiac surgery. J Nurs UFPE on line.; 8(3):719-25 . doi: 10.5205/reuol.5149-42141-1- SM .0803201429
  • Skewes SM. Skin care rituals that do more harm than good. Am J Nurs. 1996 Oct;96(10):33-5. No abstract available. PubMed 8863646 ↗
  • Şendir, M., ve Büyükyılmaz, F. (2014). Yoğun Bakım Ünitesinde Çalışan Hemşirelerin İki Farklı Yatak Banyosu Uygulamasına Ilişkin Görüşleri: YarıKalitatif Çalışma ve Maliyet Analizi. 19-22 Kasım 2014 3. Temel Hemşirelik Bakımı Kongresi Bildiri Kitabı, 19-22 Kasım, Antalya.
  • Şendir,M..(2012). Hemşirelik Esasları Uygulama Rehberi. İçinde T. Aştı ve A. Karadağ (Eds.), Kişsel Temizlik ve Giyinme Aktivitesi (2. cilt). İstanbul: İstanbul Kitapevleri ve Yayıncılık;275-279.
  • Tai CH, Hsieh TC, Lee RP. The Effect of Two Bed Bath Practices in Cost and Vital Signs of Critically Ill Patients. Int J Environ Res Public Health. 2021 Jan 19;18(2):816. doi: 10.3390/ijerph18020816. PubMed 33477909 ↗
  • Taylor, C.R., Lillis, C., LeMone, P. and Lynn, P. (2011). Fundamentals of nursing (7thed). US: Lippincott Williams &Wilkins
  • Toledo LV, Salgado PO, Souza CC, Brinati LM, Januario CF, Ercole FF. Effects of dry and traditional bed bathing on respiratory parameters: a randomized pilot study. Rev Lat Am Enfermagem. 2020;28:e3264. doi: 10.1590/1518-8345.3668.3264. Epub 2020 Jun 1. PubMed 32491124 ↗
  • Uludağ, S.(2022). Yoğun Bakım Hastalarında İki Banyo Yönteminin Yaşam Bulguları Ve Oksijen Satürasyonu Üzerine Etkisi. Yüksek Lisans Tezi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü. İstanbul
  • Ünsal, A.(2013). Hijyen Uygulamaları. İçinde T. Aştı ve A. Karadağ (Eds.), Hemşirelik Esasları Hemşirelik Bilimi ve Sanatı (2. cilt). İstanbul: Akademi Basım ve Yayıncılık;446-465.
  • Zaybak, A. ve Güneş, Ü. (2009). Yatağa bağımlı hastalarda yatak banyosunun yaşam bulgularına etkisi. Atatürk Üniversitesi Hemşirelik Yüksekokulu Dergisi, 12(4), 91-95.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05762081
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Sercan Kara (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Mar 9, 2023
Start date
Feb 15, 2023
Primary completion
Aug 15, 2023 (estimated)
Completion
Nov 15, 2023 (estimated)
Last update
Mar 9, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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