- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269861
Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients
Evaluation of the Relation of the Body Weight Calculated by Visual Estimation and Anthropometric Measurements to the Actual Body Weight Measured by the Patient Transfer Scale in Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In adult medicine, determining the patient's body weight by visual estimation performed by healthcare providers (nurses and doctors) is common for critically ill patients who cannot speak or stand due to acute illnesses such as loss of consciousness, circulatory shock, or acute respiratory failure. This practice often leads to the administration of the same dose of medication to many patients whose body weight may vary between 50 to 100 kilograms (kg). In cases where rapid diagnosis and treatment are crucial due to acute illness, the accurate and effective administration of dose-dependent drugs such as antibiotics, anticoagulants, vasopressors, sedatives, and analgesics is essential for treatment success. Although the average error percentage of 10-20% in estimated body weight by visual estimation may seem negligible in emergencies, it can lead to increased toxicity and costs in recombinant factor replacements, anticoagulants with a narrow therapeutic range, and various imported antibiotics. Additionally, the high error rate in estimating height by visual estimation poses a risk of causing ventilator-induced lung injury (VILI) during invasive mechanical ventilation support by inducing alveolar overdistension.
Various calculation methods have been reported for estimating body weight based on anthropometric measurements. One such method is weight calculation based on the upper mid-arm circumference (UMAC), which has been reported as the most correlated calculation for actual body weight in the adult age group in studies using National Health and Nutrition Examination Survey (NHANES) data in the United States (U.S.). Another commonly used method is formulas that calculate ideal body weight based on the patient's height. This is especially crucial in critically ill patients during invasive mechanical ventilation support for acute respiratory failure. The calculation of ideal body weight using charts based on half-span or knee height can be applied in cases where patients cannot stand due to critical illness.
Many anthropometric measurements mentioned here have been conducted in different societies. They may vary according to ethnic communities, emphasizing the potential differences in body composition, such as fat and muscle mass distribution, among different ethnic groups. Considering the critical illness in the Turkish population, there is currently no detailed publication in the literature regarding the usability of estimated body weights calculated based on anthropometric measurements. Moreover, the fact that many anthropometric measurements are derived from population screening data in healthy individuals causes their application in clinical practice challenging. Validity of anthropometric measurements that apply to critically ill patients, where patients cannot stand, appropriate positions for anthropometric measurements cannot be provided, and body distributions in limbs where anthropometric measurements are derived may differ due to peripheral edema, is, therefore, crucial.
In many studies using anthropometric measurements for weight calculation, the actual body weights of patients were measured using a calibrated scale. Given that critically ill patients often cannot be lifted due to acute illness, special devices or equipments are needed to reliably determine actual body weights in the supine position in this patient group. Currently, used bed scales, wall-mounted levers, or special devices that allow the patient and bed to be weighed together are not widely used due to high costs and difficulties associated with patient transfer from bed to bed, such as the need for the patient to be hemodynamically stable, the need for multiple personnel during patient transfer, adherence to infection prevention rules, and the time-consuming nature of measurements depending on the device used. The recently developed patient transfer scale, Marsden M-999®, which has advantages for patients who cannot stand, suggests that it could be used to calculate actual weight rapidly and accurately in critically ill patients. There is no publication currently in the literature about the routine use of the mentioned patient transfer scale in critically ill settings. However, its ease of use in measuring patient body weight in the supine position while transitioning from a stretcher to an intensive care bed is a significant advantage.
Considering that the patient transfer scale cannot be provided to every intensive care unit due to its cost; it was aimed to determine the most valid estimated body weight calculation method in the critically ill Turkish patients according to anthropometric measurements in this study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nazlıhan Boyacı Dündar, asist. prof.
- Phone Number: +903122024241
- Email: nazlihan@gazi.edu.tr
Study Contact Backup
- Name: Kamil İnci, asist. prof.
- Phone Number: +905442122545
- Email: kamilinci@gmail.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06560
- Recruiting
- Gazi University
-
Contact:
- Nazlıhan Boyacı Dündar, assist.prof.
- Phone Number: +905054790794
- Email: nazlihan_boyaci@yahoo.com
-
Contact:
- Kamil İnci, assist.prof.
- Phone Number: +905442122545
- Email: kamilinci@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who can stand without assistance are admitted to the inward of the internal disease department.
- Patients who are admitted to the medical intensive care units
Exclusion Criteria:
- Patient or control group under the age of 18 years
- Patients died within the first 8 hours after hospital admission
- Patients who did not sign informed consent
- Refusal of legal representative to participate in the study in unconscious patients
- Patients with anatomical defects or limb instruments that would prevent performing anthropometric measurements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: inward patients
The inward patients who will be weighed with bathroom scale and patient transfer scale
|
patient transfer scale is a device to measure actual weight for critically ill patient who are unable to stand
|
Other: critically ill patients
The critically ill patients who will be weighed with patient transfer scale
|
patient transfer scale is a device to measure actual weight for critically ill patient who are unable to stand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determining actual weight
Time Frame: Actual body weight measured with bathroom scales and patient transfer scales in standing patients on the day of hospital; up to 8 weeks for purpose of reaching total patients number of 100
|
The correlation between actual weight measured with bathroom scales and patient transfer scales in standing patients
|
Actual body weight measured with bathroom scales and patient transfer scales in standing patients on the day of hospital; up to 8 weeks for purpose of reaching total patients number of 100
|
determining the ideal estimated body weight in critically ill patients
Time Frame: Actual and estimated weight of patients determined on the first day of intensive care unit; up to 6 months for purpose of reaching total patients number of 100
|
The correlation of actual weight with estimated weight determined based on visual estimation and anthropometric measurements in critically ill
|
Actual and estimated weight of patients determined on the first day of intensive care unit; up to 6 months for purpose of reaching total patients number of 100
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nazlıhan Boyacı Dündar, asist. prof., Gazi University, Faculty of Medicine
Publications and helpful links
General Publications
- Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Cattermole GN, Graham CA, Rainer TH. Mid-arm circumference can be used to estimate weight of adult and adolescent patients. Emerg Med J. 2017 Apr;34(4):231-236. doi: 10.1136/emermed-2015-205623. Epub 2016 Dec 19.
- Maskin LP, Attie S, Setten M, Rodriguez PO, Bonelli I, Stryjewski ME, Valentini R. Accuracy of weight and height estimation in an intensive care unit. Anaesth Intensive Care. 2010 Sep;38(5):930-4. doi: 10.1177/0310057X1003800519.
- Bloomfield R, Steel E, MacLennan G, Noble DW. Accuracy of weight and height estimation in an intensive care unit: Implications for clinical practice and research. Crit Care Med. 2006 Aug;34(8):2153-7. doi: 10.1097/01.CCM.0000229145.04482.93.
- Breuer L, Nowe T, Huttner HB, Blinzler C, Kollmar R, Schellinger PD, Schwab S, Kohrmann M. Weight approximation in stroke before thrombolysis: the WAIST-Study: a prospective observational "dose-finding" study. Stroke. 2010 Dec;41(12):2867-71. doi: 10.1161/STROKEAHA.110.578062. Epub 2010 Nov 11.
- Venkataraman R, Ranganathan L, Nirmal V, Kameshwaran J, Sheela CV, Renuka MV, Ramakrishnan N. Height measurement in the critically ill patient: A tall order in the critical care unit. Indian J Crit Care Med. 2015 Nov;19(11):665-8. doi: 10.4103/0972-5229.169342.
- L'her E, Martin-Babau J, Lellouche F. Accuracy of height estimation and tidal volume setting using anthropometric formulas in an ICU Caucasian population. Ann Intensive Care. 2016 Dec;6(1):55. doi: 10.1186/s13613-016-0154-4. Epub 2016 Jun 21.
- Hickson M, Frost G. A comparison of three methods for estimating height in the acutely ill elderly population. J Hum Nutr Diet. 2003 Feb;16(1):13-20. doi: 10.1046/j.1365-277x.2003.00416.x.
- Bassey EJ. Demi-span as a measure of skeletal size. Ann Hum Biol. 1986 Sep-Oct;13(5):499-502. doi: 10.1080/03014468600008661.
- Chumlea WC, Guo S, Roche AF, Steinbaugh ML. Prediction of body weight for the nonambulatory elderly from anthropometry. J Am Diet Assoc. 1988 May;88(5):564-8.
- Opdam MH, Koekkoek KWAC, Boeije T, Mullaart N, van Zanten ARH. Mid-arm circumference method is invalid to estimate the body weight of elderly Emergency Department patients in the Netherlands. Medicine (Baltimore). 2019 Aug;98(32):e16722. doi: 10.1097/MD.0000000000016722.
- Kokong DD, Pam IC, Zoakah AI, Danbauchi SS, Mador ES, Mandong BM. Estimation of weight in adults from height: a novel option for a quick bedside technique. Int J Emerg Med. 2018 Nov 27;11(1):54. doi: 10.1186/s12245-018-0212-9.
- Freitag E, Edgecombe G, Baldwin I, Cottier B, Heland M. Determination of body weight and height measurement for critically ill patients admitted to the intensive care unit: A quality improvement project. Aust Crit Care. 2010 Nov;23(4):197-207. doi: 10.1016/j.aucc.2010.04.003. Epub 2010 Jun 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziUtipNBDundar003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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