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Postoperative respiratory complications are common complications of patients after cardiac surgery and increase morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction accounts for between 2 and 15% of these complications. Diaphragmatic paresis is one of these dysfunctions and could be due to an intra-operative phrenic nerve injury or harvesting of a mammary artery responsible for diaphragmatic devascularization. It alters the ventilatory mechanics and causes acute respiratory distress often requiring the use of mechanical ventilation. The diagnosis of this dysfunction can be made by thoracic ultrasound with assessment of diaphragmatic excursion. For patient with paresis, ultrasound criteria is an excursion < 25 mm after deep inspiration for at least one of the two hemidiaphragms. This dysfunction is most often transient in the postoperative period, but it can also become persistent.
Contract-Relax (CR) physical therapy technique can be applied to any muscle, providing muscle strengthening, neuromotor stimulation, and a gain in joint amplitude.
Currently, post-cardiac surgery management of respiratory physiotherapy is the same for a patient with or without paresis. Moreover, the CR technique of the diaphragm is not part of this "standard" rehabilitation.
The objective of this study is to determine if the CR technique associated with the current respiratory management allows an early rehabilitation of patients with diaphragmatic paresis after cardiac surgery.
This is a single-center, prospective, comparative, randomized, controlled, parallel group, single blind study, trial assessing the efficacy of the association of CR with a "standard" respiratory rehabilitation for patient with diaphragmatic paresis after cardiac surgery.
This study compares two group :
Diaphragmatic excursion will be assessed by thoracic ultrasound in time motion (TM) mode at D3 and D5, before the first physiotherapy session of the day.
The probe is placed on the mid-clavicular line under the costal grill, with an orientation at 90° of the diaphragmatic dome. The aim is to see the diaphragm through an acoustic window: the liver on the right and the spleen on the left. The diaphragm appears as a hyper echogenic line, the excursion is measured with the TM mode.
Oxygen saturation SpO2 will be taken before and after each respiratory physiotherapy session taking place at D3 and D4. A measurement will be taken on D5 before the first rehabilitation session of the day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual technique | Active Comparator | Standard rehabilitation |
|
| CR technique | Experimental | Standard rehabilitation + 3 CR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual physical therapy | Procedure | Standard rehabilitation for diaphragmatic paresis
|
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic Excursion in Maximum Inspiration | Diaphragmatic excursion ratio during maximum inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1max, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2max, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2max/M1max). | Days 3 and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic Excursion in Normal Inspiration | Diaphragmatic excursion ratio during normal inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1rest, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2rest, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2rest/M1rest). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Technique | Standard rehabilitation |
| FG001 | CR Technique | Standard rehabilitation + 3 CR |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Technique | Standard rehabilitation |
| BG001 | CR Technique | Standard rehabilitation + 3 CR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diaphragmatic Excursion in Maximum Inspiration | Diaphragmatic excursion ratio during maximum inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1max, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2max, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2max/M1max). | The analysis was performed separately for the left and right sides, and not all patients had bilateral diaphragmatic paresis. | Posted | Median | Inter-Quartile Range | ratio | Days 3 and 5 |
|
from Baseline (Day 0) through Day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Technique | Standard rehabilitation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maxence BURELLE | CMC Ambroise Paré Hartmann | 01 46 41 31 26 | +33 | recherche@clinique-a-pare.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2021 | Apr 20, 2026 | Prot_SAP_000.pdf |
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To minimize assessment bias, investigators and evaluators (doctor and ultrasound operator) will be unaware of the intervention group. Only the physiotherapist, who will realize the procedure, and the patient will know the arm of randomization.
| Contract-Relax technique | Procedure | The diaphragmatic CR is done in a semi-sitting position. The CR is composed of 4 steps :
|
|
| Days 3 and 5 |
| Oxygen Saturation | SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5. | Days 3, 4 and 5 |
| Non-invasive Ventilation | Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours). | from Baseline (Day 0) through Day 30 |
| Oxygenation | Time of oxygen therapy weaning (days). The reference time t0 will be the time of postoperative extubation. | from Baseline (Day 0) through Day 30 |
| Incidence of Respiratory Complications | Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax. | from Baseline (Day 0) through Day 30 |
| Intensive Care Unit ICU Length of Stay | Duration of ICU stay (days). | from Baseline (Day 0) through Day 30 |
| Hospital Length of Stay | Duration of hospitalization (days). | from Baseline (Day 0) through Day 30 |
| Pain Score : Numeric Rating Scale (NRS) | Self-assessment by the patient of the pain felt with a Numeric Rating Scale (NRS) from 0 (No pain) to 10 (Worst Possible Pain) after each session of respiratory physiotherapy at D3 and D4. | Days 3 and 4 |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Laterality of diaphragmatic paresis | Count of Participants | Participants |
|
| CR Technique |
Standard rehabilitation + 3 CR |
|
|
| Secondary | Diaphragmatic Excursion in Normal Inspiration | Diaphragmatic excursion ratio during normal inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1rest, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2rest, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2rest/M1rest). | The analysis was performed separately for the left and right sides, and not all patients had bilateral diaphragmatic paresis. | Posted | Median | Inter-Quartile Range | ratio | Days 3 and 5 |
|
|
|
| Secondary | Oxygen Saturation | SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5. | Posted | Median | Inter-Quartile Range | Percentage of oxygenated hemoglobin | Days 3, 4 and 5 |
|
|
|
| Secondary | Non-invasive Ventilation | Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours). | Patients requiring noninvasive ventilation. | Posted | Median | Inter-Quartile Range | hours | from Baseline (Day 0) through Day 30 |
|
|
|
| Secondary | Oxygenation | Time of oxygen therapy weaning (days). The reference time t0 will be the time of postoperative extubation. | Posted | Median | Inter-Quartile Range | days | from Baseline (Day 0) through Day 30 |
|
|
|
| Secondary | Incidence of Respiratory Complications | Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax. | Posted | Count of Participants | Participants | from Baseline (Day 0) through Day 30 |
|
|
|
| Secondary | Intensive Care Unit ICU Length of Stay | Duration of ICU stay (days). | Posted | Median | Inter-Quartile Range | days | from Baseline (Day 0) through Day 30 |
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| Secondary | Hospital Length of Stay | Duration of hospitalization (days). | Posted | Median | Inter-Quartile Range | days | from Baseline (Day 0) through Day 30 |
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|
|
| Secondary | Pain Score : Numeric Rating Scale (NRS) | Self-assessment by the patient of the pain felt with a Numeric Rating Scale (NRS) from 0 (No pain) to 10 (Worst Possible Pain) after each session of respiratory physiotherapy at D3 and D4. | Posted | Median | Inter-Quartile Range | Score on a scale | Days 3 and 4 |
|
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | CR Technique | Standard rehabilitation + 3 CR | 0 | 13 | 0 | 13 | 0 | 13 |
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| Bilateral |
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| Left-sided diaphragmatic excursion ratio |
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| SpO2 Day3 - Before physiotherapy session 2 |
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| SpO2 Day3 - After physiotherapy session 2 |
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| SpO2 Day3 - Before physiotherapy session 3 |
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| SpO2 Day3 - After physiotherapy session 3 |
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| SpO2 Day3 - Before physiotherapy session 4 |
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| SpO2 Day3 - After physiotherapy session 4 |
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| SpO2 Day4 - Before physiotherapy session 1 |
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| SpO2 Day4 - After physiotherapy session 1 |
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| SpO2 Day4 - Before physiotherapy session 2 |
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| SpO2 Day4 - After physiotherapy session 2 |
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| SpO2 Day4 - Before physiotherapy session 3 |
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| SpO2 Day4 - After physiotherapy session 3 |
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| SpO2 Day4 - Before physiotherapy session 4 |
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| SpO2 Day4 - After physiotherapy session 4 |
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| SpO2 Day5 |
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| Atelectasis |
|
| Bronchial fibroscopy |
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| Bronchospasm |
|
| Pleural effusion |
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| Pneumothorax |
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| NRS Day3 - physiotherapy session 3 |
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| NRS Day3 - physiotherapy session 4 |
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| NRS Day4 - physiotherapy session 1 |
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| NRS Day4 - physiotherapy session 2 |
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| NRS Day4 - physiotherapy session 3 |
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| NRS Day4 - physiotherapy session 4 |
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