- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07839468
Patients´ Experiences of Calorimetry Measurements
A severe burn injury affects not only the skin but also how the body uses energy. Many patients have increased energy needs during recovery, and healthcare professionals use a method called indirect calorimetry to measure the body's energy expenditure and help provide appropriate nutritional treatment.
During the measurement, the patient rests comfortably while wearing a transparent canopy over the head for approximately 10 to 30 minutes. The equipment measures oxygen consumption and carbon dioxide production to estimate the body's energy needs.
Although indirect calorimetry is commonly used in burn care, little is known about how patients experience the procedure. The aim of this study is to explore patients' experiences of undergoing indirect calorimetry after a burn injury.
Participants will be interviewed about their experiences of the measurement. By analyzing these interviews, we hope to gain a better understanding of patients' perspectives and identify ways to improve information, preparation, comfort, and overall care related to the procedure. Ultimately, this may help make the assessment more comfortable for patients and support high-quality individualized nutritional treatment.
Přehled studie
Postavení
Podmínky
Detailní popis
Severe burn injury affects the entire body, not only the skin. Profound alterations occur in metabolism, endocrine function, and immune responses, resulting in a hypermetabolic state. This condition is characterized by an increased energy expenditure that may persist for months or even years following injury. Adequate nutritional support is essential to promote wound healing, reduce the risk of infection, and preserve lean body mass. Both underfeeding and overfeeding may adversely affect recovery and clinical outcomes.
To enable safe and individualized nutritional management, measurement of resting energy expenditure (REE) using indirect calorimetry is recommended. During the assessment, the awake patient wears a transparent plastic canopy placed over the head. Oxygen consumption and carbon dioxide production are measured over a period of 10 to 30 minutes to estimate energy requirements. Accurate measurements require the patient to remain still, relaxed, and awake, while refraining from speaking, as physical activity, psychological stress, and other disturbances may influence the results.
Although indirect calorimetry is routinely used in burn care, relatively little is known about how patients experience the measurement procedure itself. Factors such as the hospital environment, pain, anxiety, restricted mobility, and the measurement may influence the patient's experience; however, these aspects have received limited scientific attention. Understanding the patient perspective is important, as discomfort or stress may negatively affect both the patient experience and the quality of the measurement.
The aim of this study is therefore to explore how individuals receiving care for burn injuries experience the assessment of resting energy expenditure by indirect calorimetry.
Data will be collected through semi-structured interviews. Eligible participants will be approached during their burn care admission and provided with both oral and written study information. Written informed consent will be obtained prior to participation. Consent forms and interview data will be stored securely and will be accessible only to the research team.
Interviews will be conducted within two weeks of the indirect calorimetry assessment, either in person at the burn unit or remotely via telephone or video call following hospital discharge. All interviews will be audio-recorded and transcribed verbatim. The interview guide focuses on participants' experiences before, during, and after the indirect calorimetry measurement.
Data will be analyzed using inductive qualitative content analysis. Interview transcripts will be read repeatedly to achieve immersion in the data and identify meaning units, which will be condensed, coded, and grouped into subcategories, categories, and overarching themes. Two researchers will independently code the interviews and discuss interpretations until consensus is reached. The analysis will involve an iterative process of moving between the original text, codes, categories, and emerging themes to develop a comprehensive understanding of participants' experiences. Findings will be reported with illustrative quotations to enhance transparency and trustworthiness.
Through qualitative content analysis of interview data, the study seeks to provide an in-depth understanding of patients' experiences, perceptions, and needs associated with indirect calorimetry. Increased knowledge in this area may contribute to improvements in clinical procedures, patient communication, and preparation before and during the assessment. Ultimately, the goal is to make the measurement process as safe, comfortable, and patient-centered as possible, thereby enhancing both the patient experience and the quality of the measurements used to guide individualised nutritional therapy.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Josefin Dimander, PhD, PhD
- Telefonní číslo: +(46)0186170489
- E-mail: josefin.dimander@uu.se
Studijní záloha kontaktů
- Jméno: Anna Stenson Zerpe, PhD, PhD
- Telefonní číslo: +46(0)186119466
- E-mail: anna.zerpe@uu.se
Studijní místa
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Uppsala, Švédsko, 75185
- Uppsala university hospital
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Kontakt:
- Josefin Dimander, PhD, PhD
- Telefonní číslo: +46(0)186170489
- E-mail: josefin.dimander@uu.se
-
Kontakt:
- Anna Stenson Zerpe, PhD
- Telefonní číslo: +46(0)186119466
- E-mail: anna.zerpe@uu.se
-
Vrchní vyšetřovatel:
- Josefin Dimander, PhD
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Vrchní vyšetřovatel:
- Anna Stenson Zerpe, PhD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Patients post-burn admitted to the BurnCentre at Uppsala university hospital, 18 years or older, swedish/english speaking, with experience of at least one calorimetry measurement.
Popis
Inclusion Criteria:
- Patients post-burn admitted to the BurnCentre at Uppsala university hospital
- 18 years or older
- Swedish/english speaking
- With experience of at least one calorimetry measurement during burn care post-trauma
Exclusion Criteria:
- Not fulfilling inclusion criteria
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: OTHER
Kohorty a intervence
Skupina / kohorta |
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Patients post-burn
Patients post-burn admitted to the BurnCentre at Uppsala university hospital, 18 years or older, swedish/english speaking, with experience of at least one calorimetry measurement. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patients´ experiences
Časové okno: The interviews will be conducted within two weeks from the calorimetry measurment.
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Patients´ experiences before, during and after calorimetry measurement is explored with a semi-structered interview guide. The interview will be conducted within two weeks from the measurment at the Burn Centre. The interviews will be recorded, transcribed and analysed with content analysis. |
The interviews will be conducted within two weeks from the calorimetry measurment.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
- Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
- Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3.
- Rousseau AF, Losser MR, Ichai C, Berger MM. ESPEN endorsed recommendations: nutritional therapy in major burns. Clin Nutr. 2013 Aug;32(4):497-502. doi: 10.1016/j.clnu.2013.02.012. Epub 2013 Mar 14.
- Oshima T, Berger MM, De Waele E, Guttormsen AB, Heidegger CP, Hiesmayr M, Singer P, Wernerman J, Pichard C. Indirect calorimetry in nutritional therapy. A position paper by the ICALIC study group. Clin Nutr. 2017 Jun;36(3):651-662. doi: 10.1016/j.clnu.2016.06.010. Epub 2016 Jun 22.
- Caldis-Coutris N, Gawaziuk JP, Magnusson S, Logsetty S. Malnutrition in Burns: A Prospective, Single-Center Study. J Burn Care Res. 2022 May 17;43(3):592-595. doi: 10.1093/jbcr/irab186.
- Lengele L, Bruyere O, Fadeur M, Verbrugge AM, Martin F, Hans N, Misset B, Rousseau AF. Should We Worry About Nutrition Of Adults With Minor Burns? An Audit Of Their Intakes. Ann Burns Fire Disasters. 2021 Jun 30;34(2):163-169.
- Chourdakis M, Bouras E, Shields BA, Stoppe C, Rousseau AF, Heyland DK. Nutritional therapy among burn injured patients in the critical care setting: An international multicenter observational study on "best achievable" practices. Clin Nutr. 2020 Dec;39(12):3813-3820. doi: 10.1016/j.clnu.2020.04.023. Epub 2020 Apr 21.
- Berger MM, Reintam-Blaser A, Calder PC, Casaer M, Hiesmayr MJ, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Bischoff SC, Singer P. Monitoring nutrition in the ICU. Clin Nutr. 2019 Apr;38(2):584-593. doi: 10.1016/j.clnu.2018.07.009. Epub 2018 Jul 20.
- Singer P. Preserving the quality of life: nutrition in the ICU. Crit Care. 2019 Jun 14;23(Suppl 1):139. doi: 10.1186/s13054-019-2415-8.
- Jeschke MG. Postburn Hypermetabolism: Past, Present, and Future. J Burn Care Res. 2016 Mar-Apr;37(2):86-96. doi: 10.1097/BCR.0000000000000265.
- Wise AK, Hromatka KA, Miller KR. Energy Expenditure and Protein Requirements Following Burn Injury. Nutr Clin Pract. 2019 Oct;34(5):673-680. doi: 10.1002/ncp.10390. Epub 2019 Aug 16.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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