NCT06402903

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1 day

First QC Date

May 2, 2024

Last Update Submit

May 21, 2024

Conditions

Keywords

PhysiotherapyIntensive Care UnitPostoperative complications preventionCardiac surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Assess the age

    Screening visit

  • Assess the gender

    Screening visit

  • Assess the weight

    Screening visit

  • Assess the administration of a physiotherapy intervention

    Screening visit

Study Arms (1)

Observacional group

The data will be collected in April 2024 at the Physical Medicine and Rehabilitation Service of the Central University Hospital of Asturias (HUCA), belonging to Health Area IV of the Health Service of the Principality of Asturias.

Other: Observation

Interventions

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).

Observacional group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The data will be collected in May 2024 at the Physical Medicine and Rehabilitation Service of the Hospital Universitario Central de Asturias (HUCA), belonging to the Health Area IV of the Health Service of the Principality of Asturias.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

May 6, 2024

Primary Completion

May 7, 2024

Study Completion

May 20, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations