Heart SurgeryPaFiKinESAPNCT05470686
Study of the Relationship Between the Oxygenation State and Lung Ultrasound Score in Cardiac Surgery
A study testing blood gas via arterial catheter in people with Heart Surgery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery
- What is being tested?
- blood gas via arterial catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2023to Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- Person having received complete information on the organization of the research and having given written consent to participate
- Person having benefited from a heart surgery under cardio-pulmonary bypass
- Medical prescriptions for non invasive ventilation and physiotherapist
- Age ≥ 18 years
- 18.5 ≤ BMI ≤ 35 kg/m2
- Visual Analogy Scale pain < 4
- Patient conscious and oriented: Glasgow 15/15
Who cannot join
- At the patient's request : a patient may withdraw from the research at any time without affecting the quality of care to which he or she is entitled (withdrawal of consent).
- Cardiorespiratory arrest during the inclusion visit.
- Need for orotracheal reintubation during the inclusion visit.
- Patient non-cooperation during the inclusion visit.
- Failure of the ultrasound machine during the inclusion visit.
- Failure of the blood gas analyzer.
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- Glasgow < 15 during the inclusion visit
- PEEP > 6 cmH2O required during physiotherapy + non invasive ventilation session
- PEEP < 6 cmH2O required during physiotherapy + non invasive ventilation session
- Premature interruption of the physiotherapy session + non invasive ventilation not hemodynamically tolerated
- Need for a session of non invasive ventilation + physiotherapy > 30 minutes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
centralHNF
Vandœuvre-lès-Nancy, 54511
Aurelie ROTH OUDIN, 03 83 15 41 96, a.roth@chru-nancy.fr
About this study
Official title: Study of the Relationship Between the Relative Variation of PaO2/FiO2 and the Variation of Lung Ultrasound Score During the First Session of Physiotherapy Associated With Non-invasive Ventilation in Cardiac Surgery Patients by Cardiopulmonary Bypass
After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation.
Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients
Read more
Secondary objectives
- To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement.
- To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score
- To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio
- To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV
- To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session
- Conditions
- Heart Surgery
- Being tested
- blood gas via arterial catheter
- Keywords
- heart surgery, Lung ultrasound score, PaO2/FiO2 ration, physiotherapy, Non invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood gas via arterial catheterBiological
Also called Lung ultrasound score
Patients will have a blood sample plus a lung ultrasound before and after the physical therapy session combined with non invasive ventilation the morning after the heart surgery
| Study group | Role | What they receive |
|---|---|---|
| HEART SURGERY PATIENTS with cardio pulmonary bypass | Other | Not described Receives: Biological: blood gas via arterial catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)
The higher the ratio, better is the result. Between approximately 0 and 400
Measured: the morning after the heart surgery
Difference in lung ultrasound score: measurement after - measurement before the physiotherapy session + non invasive ventilation
Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows:
0 = normal ventilation
- = multiple B-lines defined
- = coalescing B-lines
- = pulmonary consolidation
Measured: the morning after the heart surgery
Secondary outcomes (6)
Lung ultrasound score values obtained by both evaluators from the same recorded ultrasound images. If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.
If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.
Measured: in the week following the measurements
relative difference in PaO2/FiO2 ratio
The higher the ratio, better is the result. Between approximately 0 and 400
Measured: the morning after the heart surgery
difference in lung ultrasound score for each study area
Each zone is rated from 0 to 3 points. The lower the score, the better the result. We look to see if the score for each zone decreases between before and after the physiotherapy session.
Measured: the morning after the heart surgery
initial lung ultrasound score
Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows:
0 = normal ventilation
- = multiple B-lines defined
- = coalescing B-lines
- = pulmonary consolidation
Measured: the morning after the heart surgery
relative difference in PaCO2
The lower the score, the better the result. Ap proximately between 0 and 100
Measured: the morning after the heart surgery and after physiotherapy session
For each subject, answers to two questions at the end of the session about his or her understanding of PAS after the information provided by the MK during the session
Questions asked by the physiotherapist for the patient (at the end of the session) :
- Did you understand the explanations provided by the physiotherapist regarding the lung ultrasound results? Yes, completely Yes, partially No No answer
- Did the explanations provided by the physiotherapist regarding the results of the lung ultrasound score help you understand the movements or displacements that the physiotherapist asked you to make during this session? Yes, completely Yes, partially No No answer
Translated with www.DeepL.com/Translator (free version)
Measured: the morning after the heart surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start21 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurelie OUDIN-ROTH, Central Hospital, Nancy, France
- Investigators
- Jean PAYSANT, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470686
- Sponsor's protocol ID
- 2022-A01478-35
- Acronym
- PaFiKinESAP
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between the Relative Variation of PaO2/FiO2 and the Variation of Lung Ultrasound Score During the First Session of Physiotherapy Associated With Non-invasive Ventilation in Cardiac Surgery Patients by Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05470686
- Acronym / sponsor ID
- PaFiKinESAP / 2022-A01478-35
- Conditions
- Heart Surgery
- Keywords
- heart surgery, Lung ultrasound score, PaO2/FiO2 ration, physiotherapy, Non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Jul 2022 (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.
After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation.
Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients
Secondary objectives
- To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement.
- To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score
- To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio
- To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV
- To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEART SURGERY PATIENTS with cardio pulmonary bypass | Other | Biological: blood gas via arterial catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Person having received complete information on the organization of the research and having given written consent to participate
- Person having benefited from a heart surgery under cardio-pulmonary bypass
- Medical prescriptions for non invasive ventilation and physiotherapist
- Age ≥ 18 years
- 18.5 ≤ BMI ≤ 35 kg/m2
Key exclusion criteria (11 listed)
- At the patient's request : a patient may withdraw from the research at any time without affecting the quality of care to which he or she is entitled (withdrawal of consent).
- Cardiorespiratory arrest during the inclusion visit.
- Need for orotracheal reintubation during the inclusion visit.
- Patient non-cooperation during the inclusion visit.
- Failure of the ultrasound machine during the inclusion visit.
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 |
|---|---|---|
| blood gas via arterial catheterAlso: Lung ultrasound scorePatients will have a blood sample plus a lung ultrasound before and after the physical therapy session combined with non invasive ventilation the morning after the heart surgery | Biological | HEART SURGERY PATIENTS with cardio pulmonary bypass |
Primary outcome
Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)
Time frame: the morning after the heart surgery
The higher the ratio, better is the result. Between approximately 0 and 400
Difference in lung ultrasound score: measurement after - measurement before the physiotherapy session + non invasive ventilation
Time frame: the morning after the heart surgery
Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows: 0 = normal ventilation 1. = multiple B-lines defined 2. = coalescing B-lines 3. = pulmonary consolidation
6 secondary outcomes
Lung ultrasound score values obtained by both evaluators from the same recorded ultrasound images. If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.
Time frame: in the week following the measurements
relative difference in PaO2/FiO2 ratio
Time frame: the morning after the heart surgery
difference in lung ultrasound score for each study area
Time frame: the morning after the heart surgery
initial lung ultrasound score
Time frame: the morning after the heart surgery
relative difference in PaCO2
Time frame: the morning after the heart surgery and after physiotherapy session
For each subject, answers to two questions at the end of the session about his or her understanding of PAS after the information provided by the MK during the session
Time frame: the morning after the heart surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Jean PAYSANT study director
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?
A study testing blood gas via arterial catheter in people with Heart Surgery, 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 7 inclusion and 11 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 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie roth oudin (03 83 15 41 96, a.roth@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.) (time frame: the morning after the heart surgery). 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 21 Aug 2024.