Adverse EventAdephysioNCT03552887
Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery
An observational study of Adverse Event and Physiotherapy, run by University of Sao Paulo General Hospital.
Trial summary
This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Event, Physiotherapy, Intensive Care Units
- What is being tested?
- Cardiac Surgery and Physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted at surgical ICU, undergoing cardiac surgery, and who had receive any physiotherapy intervention, at Instituto do Coracao - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Brazil
Who may be able to join
- Patients undergoing cardiac surgery
- Age ≥ 18 years old
- Patients who are receiving any physiotherapy intervention
Who cannot join
- Neurological and cognitive impairment
About this study
This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. This is a prospective cohort study, and the investigators observed all types of physiotherapy interventions in patients admitted at surgical ICU.
Read the detailed description
Physiotherapy intervention practice in patients after cardiac surgery has been associated with better clinical outcomes, but the safety of such interventions are not fully understood.
A prospective observational study of patients admitted at surgical ICU, aged > 18 years old, undergoing cardiac surgery was conducted to estimate the incidence of adverse events during physiotherapy interventions in those patients and to identify predictors of adverse events.
Physiotherapy interventions were observed, performed by physiotherapists outside of the protocol. The occurrence of adverse events or physiological abnormality were recorded, classifying them according to the symptomatic consequences for the patient, from grade 1 ("near miss", additional intervention not required) to grade 5 (death). The investigators collected clinical characteristics of patients, such as sequential organ failure assessment (SOFA) score, comorbidities, sedation leve and pain. Participants were followed up to hospital discharge.
- Being tested
- Cardiac Surgery, Physiotherapy
- Keywords
- Adverse Event, Physiotherapy, Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Any type of cardiac surgery
PhysiotherapyProcedure or surgery
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol
| Study group | Role | What they receive |
|---|---|---|
| Postoperative patients | Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention Receives: Procedure: Cardiac Surgery; Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Occurrence of adverse events during all physiotherapy interventions.
Measured: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Secondary outcomes (4)
Grade of adverse event
Grade of observed adverse event according to the symptomatic consequences for the patient, from grade 1 ("near miss", additional intervention not required) to grade 5 (death)
Measured: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Mortality Rate
Number of deaths
Measured: Until hospital discharge, up to 24 months
ICU Length of Stay
Number of days in ICU
Measured: Until ICU discharge, up to 24 months
Hospital Length of Stay
Number of days in hospital
Measured: Until hospital discharge, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Jun 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital
- Investigators
- Emilia Nozawa, PhD, PT, Principal investigator, Instituto do Coracao, Hospital das Clinicas, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552887
- Sponsor's protocol ID
- 1391854
- Other IDs
- 51256215.5.0000.0068
- Acronym
- Adephysio
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual personal data will be disclosed
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03552887
- Acronym / sponsor ID
- Adephysio / 1391854
- Keywords
- Adverse Event, Physiotherapy, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 Jun 2018 (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.
This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. This is a prospective cohort study, and the investigators observed all types of physiotherapy interventions in patients admitted at surgical ICU.
Detailed description
Physiotherapy intervention practice in patients after cardiac surgery has been associated with better clinical outcomes, but the safety of such interventions are not fully understood.
A prospective observational study of patients admitted at surgical ICU, aged > 18 years old, undergoing cardiac surgery was conducted to estimate the incidence of adverse events during physiotherapy interventions in those patients and to identify predictors of adverse events.
Physiotherapy interventions were observed, performed by physiotherapists outside of the protocol. The occurrence of adverse events or physiological abnormality were recorded, classifying them according to the symptomatic consequences for the patient, from grade 1 ("near miss", additional intervention not required) to grade 5 (death). The investigators collected clinical characteristics of patients, such as sequential organ failure assessment (SOFA) score, comorbidities, sedation leve and pain. Participants were followed up to hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative patients | – | Procedure: Cardiac Surgery, Procedure: PhysiotherapyCohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted at surgical ICU, undergoing cardiac surgery, and who had receive any physiotherapy intervention, at Instituto do Coracao - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Brazil
Key inclusion criteria (3 listed)
- Patients undergoing cardiac surgery
- Age ≥ 18 years old
- Patients who are receiving any physiotherapy intervention
Key exclusion criteria (1 listed)
- Neurological and cognitive impairment
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 |
|---|---|---|
| Cardiac SurgeryAny type of cardiac surgery | Procedure or surgery | Postoperative patients |
| PhysiotherapyAny type of physiotherapy intervention, performed by physiotherapists outside of the protocol | Procedure or surgery | Postoperative patients |
Primary outcome
Adverse Event
Time frame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Occurrence of adverse events during all physiotherapy interventions.
4 secondary outcomes
Grade of adverse event
Time frame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Mortality Rate
Time frame: Until hospital discharge, up to 24 months
ICU Length of Stay
Time frame: Until ICU discharge, up to 24 months
Hospital Length of Stay
Time frame: Until hospital discharge, up to 24 months
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 25 Jun 2018.
- Individual participant dataSharing planned: No. No individual personal data will be disclosed
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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.
Emilia Nozawa, PhD, PT principal investigator
Instituto do Coracao, Hospital das Clinicas, USP
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Event and Physiotherapy, run by University of Sao Paulo General Hospital.
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 3 inclusion and 1 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Adverse Event (time frame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months). 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 25 Jun 2018.