Cardiac Surgery PatientsNCT06402903
Physiotherapy in Patients in a Cardiac Intensive Care Unit
An observational study of Cardiac Surgery Patients, run by University of Oviedo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery Patients
- What is being tested?
- Observation
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2024to 20 May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy in Patients in a Cardiac Intensive Care Unit. A Retrospective Cohort Study
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.
Read more
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.
- Conditions
- Cardiac Surgery Patients
- Being tested
- Observation
- Keywords
- Physiotherapy, Intensive Care Unit, Postoperative complications prevention, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Screening visit
Secondary outcomes (4)
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.
Measured: Screening visit
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.
Measured: Screening visit
Assess the weight
The weight at the time of the patient's admission to the hospital will be assessed (in kg)
Measured: Screening visit
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.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start6 May 2024
- Primary completion7 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402903
- Sponsor's protocol ID
- FisCard
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy in Patients in a Cardiac Intensive Care Unit. A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06402903
- Acronym / sponsor ID
- FisCard
- Conditions
- Cardiac Surgery Patients
- Keywords
- Physiotherapy, Intensive Care Unit, Postoperative complications prevention, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observacional group | – | Other: ObservationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThe 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). | Other | Observacional group |
Primary outcome
Assess length of stay in the Intensive Care Unit
Time frame: Screening visit
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.
Assess time from hospital admission to medical discharge
Time frame: Screening visit
This period shall be calculated (in days) by subtracting the date of admission to the Intensive Care Unit from the date of discharge.
4 secondary outcomes
Assess the age
Time frame: Screening visit
Assess the gender
Time frame: Screening visit
Assess the weight
Time frame: Screening visit
Assess the administration of a physiotherapy intervention
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Patients, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess length of stay in the Intensive Care Unit (time frame: Screening visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.