COVID-19NCT06042881
Retrospective Cohort Study of the Physiotherapy in Critically Ill Covid Patients
An observational study of COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Retrospective cohort study that will include patients from the ICU of the Hospital de la Santa Creu i Sant Pau in Barcelona during the period between March 11 and May 13, 2020. The cohorts are made up of two groups of patients admitted for severe COVID during the first wave, according to whether or not they received… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 189 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2023to 30 Oct 2023
- 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: The sample size obtained will not be from any formal calculation, it will be a sample per convenience of inclusion of all patients admitted to the ICU with a diagnosis of COVID-19 During the study period, 189 subjects, with whom it is expected to achieve the objectives of the study.
Who may be able to join
- Patients diagnosed with COVID-19 in critical condition
- Adults >18 years
- Admission to the ICU from March 11 to May 13, 2020
Who cannot join
- Patients readmitted on 2 occasions during the study period, the second will be omitted income.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Dolça Gras Pacheco, Msc, 684344258, dolcagras@gmail.com
About this study
Official title: Retrospective Cohort Study of the Physiotherapy Procedure in Critically Ill Patients Diagnosed With COVID-19 During the First Wave
Retrospective cohort study that will include patients from the ICU of the Hospital de la Santa Creu i Sant Pau in Barcelona during the period between March 11 and May 13, 2020. The cohorts are made up of two groups of patients admitted for severe COVID during the first wave, according to whether or not they received physiotherapy and the possible impact of physiotherapy on the days of mechanical ventilation in the two study groups will be studied.
- Conditions
- COVID-19
- Keywords
- physical therapy, covid, mechanical ventilation
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of mechanical ventilation
To evaluate the effectiveness of early physiotherapy in critically ill patients with COVID-19 admitted to the ICU in terms of reducing days of mechanical ventilation
Measured: 2 months
Secondary outcomes (7)
days of stay
Evaluate the days of stay in the ICU
Measured: 2 months
Assess morbidity and mortality.
Assess morbidity and mortality.
Measured: 2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Measured: 2 months
PNS lesion in prono position
To know if there is a greater risk of suffering a PNS lesion the more rounds of pronation
Measured: 2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
To know if the delay in the prescription of physiotherapy (FST) influences the appearance of PNS lesions.
Measured: 2 months
Start of standing in critrically ill
To evaluate the start of standing (BP) in critically ill patients infected with COVID-19 who underwent FST.
Measured: 2 months
Workload in physiotherapy
To assess the workload of the cohort of patients who underwent physiotherapy during the first wave of COVID-19.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 May 2023
- Primary completion31 Jul 2023
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Retrospective
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042881
- Sponsor's protocol ID
- IIBSP-COV-2022-36
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of the Physiotherapy Procedure in Critically Ill Patients Diagnosed With COVID-19 During the First Wave
- ClinicalTrials.gov ID
- NCT06042881
- Acronym / sponsor ID
- IIBSP-COV-2022-36
- Conditions
- COVID-19
- Keywords
- physical therapy, covid, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 21 Sep 2023 (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.
Retrospective cohort study that will include patients from the ICU of the Hospital de la Santa Creu i Sant Pau in Barcelona during the period between March 11 and May 13, 2020. The cohorts are made up of two groups of patients admitted for severe COVID during the first wave, according to whether or not they received physiotherapy and the possible impact of physiotherapy on the days of mechanical ventilation in the two study groups will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size obtained will not be from any formal calculation, it will be a sample per convenience of inclusion of all patients admitted to the ICU with a diagnosis of COVID-19 During the study period, 189 subjects, with whom it is expected to achieve the objectives of the study.
Key inclusion criteria (3 listed)
- Patients diagnosed with COVID-19 in critical condition
- Adults >18 years
- Admission to the ICU from March 11 to May 13, 2020
Key exclusion criteria (1 listed)
- Patients readmitted on 2 occasions during the study period, the second will be omitted income.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Days of mechanical ventilation
Time frame: 2 months
To evaluate the effectiveness of early physiotherapy in critically ill patients with COVID-19 admitted to the ICU in terms of reducing days of mechanical ventilation
7 secondary outcomes
days of stay
Time frame: 2 months
Assess morbidity and mortality.
Time frame: 2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Time frame: 2 months
PNS lesion in prono position
Time frame: 2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Time frame: 2 months
Start of standing in critrically ill
Time frame: 2 months
Workload in physiotherapy
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
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 COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dolça Gras Pacheco (+34684344258, dolcagras@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of mechanical ventilation (time frame: 2 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 21 Sep 2023.