Physical Therapy in Cardiac Surgery PatientsNCT04793802
Impact of Physiotherapy Session in Cardiac Surgery Patients
An observational study of Physical Therapy in Cardiac Surgery Patients, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY. Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Therapy in Cardiac Surgery Patients
- What is being tested?
- PHYSIO
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 15 Mar 2021
- 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 subjects of the study will be patients who stayed in the Cardiovascular Surgery and Cardiac Transplant Intensive Care Unit at NANCY CHRU from September 15, 2020 to March 15, 2021
Who may be able to join
- Person who has received full information on the organization of the research and has not objected to the use of the data.
- Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass
- Patient under high flow oxygenation
- Age ≥ 18 years old
- 18.5 ≤ BMI ≤ 35 kg/m2
- Conscious and oriented patients: Glasgow 15
Who cannot join
- Surgical emergencies: grafting, dissections...
- Lumbar drainage in progress
- Beating heart surgery
- Refusal to participate in the study
- Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study
This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.
Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.
Read more
The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?
Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.
Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.
- Being tested
- PHYSIO
- Keywords
- Physiotherapy, Cardiac surgery, Lung ultrasound score, Noninvasive ventilation, High flow oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSIOOther
session of physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION | Patients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation. Receives: Other: PHYSIO | |
| Patients benefiting from HIGH-FLOW OXYGENATION | Patients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation. Receives: Other: PHYSIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score
Reliable and verified score, subject to international recommendations allowing the physiotherapist to deepen his diagnosis and evaluate the effectiveness of his techniques. Measured on 12 thoracic regions The score (N B1 B2 C) will therefore be calculated according to the level obtained in each zone to determine a score out of 36. The higher the score, the more the lung has a deficit of ventilation.
A decrease in the objective lung ultrasound score will result in better lung aeration.
Two lung ultrasound score measurements are realized on one patient. The first measurement is taken on the day of inclusion of the patient in the study at the time of the physiotherapist's assessment before the CPT session. (CPT = Chest Physiotherapy Treatment) The second and last measurement is taken after the CPT session (with or without NIV, depending on the medical prescription).
Measured: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start15 Sep 2020
- Primary completion15 Sep 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Therapy in Cardiac Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAYSANT Jean, Central Hospital, Nancy, France
- Investigators
- Jean PAYSANT, MD PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793802
- Sponsor's protocol ID
- 2020PI208
- Status last verified
- May 2022
- First submitted
- 4 Dec 2020
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT04793802
- Acronym / sponsor ID
- 2020PI208
- Keywords
- Physiotherapy, Cardiac surgery, Lung ultrasound score, Noninvasive ventilation, High flow oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 11 Mar 2021 (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 work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.
Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.
The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?
Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.
Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION | – | Other: PHYSIOPatients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation. |
| Patients benefiting from HIGH-FLOW OXYGENATION | – | Other: PHYSIOPatients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of the study will be patients who stayed in the Cardiovascular Surgery and Cardiac Transplant Intensive Care Unit at NANCY CHRU from September 15, 2020 to March 15, 2021
Key inclusion criteria (6 listed)
- Person who has received full information on the organization of the research and has not objected to the use of the data.
- Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass
- Patient under high flow oxygenation
- Age ≥ 18 years old
- 18.5 ≤ BMI ≤ 35 kg/m2
Key exclusion criteria (5 listed)
- Surgical emergencies: grafting, dissections...
- Lumbar drainage in progress
- Beating heart surgery
- Refusal to participate in the study
- Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)
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 |
|---|---|---|
| PHYSIOsession of physiotherapy | Other | Patients benefiting from HIGH-FLOW OXYGENATION, Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION |
Primary outcome
Lung ultrasound score
Time frame: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.
Reliable and verified score, subject to international recommendations allowing the physiotherapist to deepen his diagnosis and evaluate the effectiveness of his techniques. Measured on 12 thoracic regions The score (N B1 B2 C) will therefore be calculated according to the level obtained in each zone to determine a score out of 36. The higher the score, the more the lung has a deficit of ventilation. A decrease in the objective lung ultrasound score will result in better lung aeration. Two lung ultrasound score measurements are realized on one patient. The first measurement is taken on the day of inclusion of the patient in the study at the time of the physiotherapist's assessment before the CPT session. (CPT = Chest Physiotherapy Treatment) The second and last measurement is taken after the CPT session (with or without NIV, depending on the medical prescription).
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 13 May 2022.
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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.
Jean PAYSANT, MD PhD principal investigator
Central Hospital, Nancy, France
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 Physical Therapy in Cardiac Surgery Patients, run by Central Hospital, Nancy, France at 1 site in France.
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 6 inclusion and 5 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 13 May 2022. 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 France. 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?
Lung ultrasound score (time frame: The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.). 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 13 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.