SternotomyNCT06153550
The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
An observational study of Sternotomy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing. There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sternotomy
- What is being tested?
- preparation in Respiratory Physiotherapy
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 10 Nov 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient with indication of cardiac surgery will be included.
Who may be able to join
- Patient with indication of cardiac surgery
Who cannot join
- Patient with a Body Mass Index (BMI) > 30
- Restrictive patient
- Obstructive patient
- Asthmatic
- Chronic Obstructive Pulmonary Disease (COPD)
- History of pulmonary fibrosis, tuberculosis
Show all 15Show fewer
- Coronary patients with stenosis of the common trunk.
- Emergency and lifesaving surgeries
- History of thoracic trauma
- Severe kyphotic patients
- History of radiotherapy
- Patients with neuromuscular disease
- Patients with thoracic cage involvement (pectus excavatum, post thoracic surgery)
- Patients with emphysema
- Patients with dilated bronchi
Trial locations and contacts
1 site in 1 country.
About this study
The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing.
There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.
Read the detailed description
The aim of the study is to have a quantification of this preparation spirometry: before starting the preparation and at the end of the preparation (right before surgery) by comparing the spirometric and pulse oximetry information. The prospective study will be conducted on 25 patients, who will be selected consecutively without randomization.
- Conditions
- Sternotomy
- Being tested
- preparation in Respiratory Physiotherapy
- Keywords
- Cardiac surgery, Sternotomy, respiration, Spirometry, pulse oximetry
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preparation in Respiratory PhysiotherapyOther
preparation in Respiratory Physiotherapy consist to:
- 3 sessions per week with the physiotherapist
- spirometry and pulse oximetry test 3 weeks before surgery, the day before surgery and the day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have sternotomy | Patients who have sternotomy wll be included. They will have preparation in Respiratory Physiotherapy before sternotomy. Receives: Other: preparation in Respiratory Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the evolution of the pulmonary function by Forced spirometry.
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Secondary outcomes (5)
Analysis of the evolution of the pulmonary function by Resistance
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Lung volumes
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Dissemination capacity,
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Flow / volume curves
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Peripheral saturation
Measured by spirometry and pulse oximetry results.
Measured: 3 weeks before, the day before and the day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Sep 2021
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andranik PETROSYAN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153550
- Sponsor's protocol ID
- IRBN522021/CHUSTE
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06153550
- Acronym / sponsor ID
- IRBN522021/CHUSTE
- Conditions
- Sternotomy
- Keywords
- Cardiac surgery, Sternotomy, respiration, Spirometry, pulse oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 1 Dec 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.
The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing.
There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.
Detailed description
The aim of the study is to have a quantification of this preparation spirometry: before starting the preparation and at the end of the preparation (right before surgery) by comparing the spirometric and pulse oximetry information. The prospective study will be conducted on 25 patients, who will be selected consecutively without randomization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have sternotomy | – | Other: preparation in Respiratory PhysiotherapyPatients who have sternotomy wll be included. They will have preparation in Respiratory Physiotherapy before sternotomy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient with indication of cardiac surgery will be included.
Key inclusion criteria (1 listed)
- Patient with indication of cardiac surgery
Key exclusion criteria (15 listed)
- Patient with a Body Mass Index (BMI) > 30
- Restrictive patient
- Obstructive patient
- Asthmatic
- Chronic Obstructive Pulmonary Disease (COPD)
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 |
|---|---|---|
| preparation in Respiratory Physiotherapypreparation in Respiratory Physiotherapy consist to: * 3 sessions per week with the physiotherapist * spirometry and pulse oximetry test 3 weeks before surgery, the day before surgery and the day after surgery. | Other | Patients who have sternotomy |
Primary outcome
Analysis of the evolution of the pulmonary function by Forced spirometry.
Time frame: 3 weeks before, the day before and the day after surgery.
Measured by spirometry and pulse oximetry results.
5 secondary outcomes
Analysis of the evolution of the pulmonary function by Resistance
Time frame: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Lung volumes
Time frame: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Dissemination capacity,
Time frame: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Flow / volume curves
Time frame: 3 weeks before, the day before and the day after surgery.
Analysis of the evolution of the pulmonary function by Peripheral saturation
Time frame: 3 weeks before, the day before and the day after surgery.
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 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Sternotomy
Recruiting
Impact of Pre- and Early Post-operative Isometric Handgrip Training on Functional Capacity and Autonomic Function After Sternotomy
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RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Not yet recruitingPhase 4
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
Cardiac Valve Disease, Coronary Heart Disease
Not yet recruiting
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
Chronic Poststernotomy Pain
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.
Andranik PETROSYAN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Sternotomy, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 15 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 Dec 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 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?
Analysis of the evolution of the pulmonary function by Forced spirometry. (time frame: 3 weeks before, the day before and the day after surgery.). 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 Dec 2023.