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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06402903
Other study ID # FisCard
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2024
Est. completion date May 20, 2024

Study information

Verified date May 2024
Source University of Oviedo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background. Cardiovascular diseases are a major cause of morbidity and mortality. The management of these patients requires multidisciplinary therapeutic approaches. Physiotherapy plays a fundamental role in the postoperative management of patients undergoing cardiac surgery. Objective: To analyse the relationship between the administration of a physiotherapy intervention and the time spent in the cardiac ICU and on the ward. Method. Retrospective cohort study. The medical records of 110 patients undergoing cardiac surgery who received a Physiotherapy intervention during their stay in the Intensive Care Unit will be analysed. Data will be collected from patients admitted to the cardiac ICU in 2023. The variables assessed will be: length of stay in ICU and hospital admission (days), age (years completed), weight (kg) and sex. A one-factor analysis of variance will be performed to calculate the association between the variables and a linear regression analysis will be used to describe the hospital stay variables as a function of the other predictor variables. Expected outcomes. Physiotherapy treatment in an Intensive Care Unit improves ICU and hospital stay times in patients undergoing cardiac surgery.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 20, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients diagnosed with cardiac pathology - Undergoing cardiac surgery at the Hospital Universitario Central de Asturias between 1 January and 31 March 2023 - In the postoperative phase in the Intensive Care Unit and subsequently on transfer to the ward, they received physiotherapy treatment or not. - That the period of stay in the ICU was less than 30 days. Exclusion Criteria: - Patients with comorbidities prior to surgery that hindered independence from third parties in the performance of activities of daily living and ambulation; iii) patients with previous cardiac surgeries; and iv) patients whose study variables were not fully recorded in the Medical History. - Patients with previous cardiac surgeries - Patients whose study variables were not fully recorded in the Clinical History.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation
The clinical, post-surgical and anthropometric variables of the patients, as well as the time spent in the Intensive Care Unit and on the hospital ward (in days) were collected in the Clinical Histories. The collection of data from the Clinical Histories will be carried out by the principal investigator, an employee of the Hospital Universitario Central de Asturias, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the patients whose data were collected. The data from the Clinical Histories will be exported to an Excel file which will subsequently be anonymised. Access to the Excel file will require a password access that will be managed from a computer of the University of Oviedo (Department of Surgery and Medical-Surgical Specialties).

Locations

Country Name City State
Spain University of Oviedo Oviedo Asturias

Sponsors (1)

Lead Sponsor Collaborator
University of Oviedo

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess length of stay in the Intensive Care Unit This period shall be calculated (in days) by subtracting the date of admission to the Intensive Care Unit from the date of discharge from the Intensive Care Unit. Screening visit
Primary Assess time from hospital admission to medical discharge This period shall be calculated (in days) by subtracting the date of admission to the Intensive Care Unit from the date of discharge. Screening visit
Secondary Assess the age This quantitative variable will indicate the age of the patients (in years of age) at the time of admission to the Intensive Care Unit. Screening visit
Secondary Assess the gender This dichotomous variable (Female / Male) will indicate the sex of the patient at the time of admission to the Intensive Care Unit. Screening visit
Secondary Assess the weight The weight at the time of the patient's admission to the hospital will be assessed (in kg) Screening visit
Secondary Assess the administration of a physiotherapy intervention This dichotomous variable (Yes / No) will indicate whether the patient has received physiotherapy intervention during his/her stay in the Intensive Care Unit. Screening visit
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