Surgery, CardiacCOREDIANCT05068219
Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery
A study testing Usual physical therapy and Contract-Relax technique in people with Surgery, Cardiac, run by CMC Ambroise Paré at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac
- What is being tested?
- Usual physical therapy and Contract-Relax technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2021to 13 Nov 2023
- Phase
- Interventional
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
- Cardiac surgery under extracorporeal circulation,
- Postoperative diaphragmatic paresis (Diaphragmatic excursion <25mm),
- Consent for participation,
- Affiliation to the social security system
Who cannot join
- History of respiratory pathologies,
- History of neurological pathologies,
- Post-operative cardiac and circulatory complications,
- Pregnant or breastfeeding women,
- Unable to understand,
- Guardianship, curators or safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Contract-Relax Technique in the Physical Therapy Management of Diaphragmatic Paresis After Cardiac Surgery
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.
Read more
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.
Read the detailed description
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 :
- "Control" group : Standard rehabilitation (4 rehabilitation sessions a day in Intensive Care Unit (ICU) and 2 sessions in cardiac surgery unit).
- "Interventional' group : Standard rehabilitation + 3 CR during each session. A stratification of the randomization is planned according to diaphragmatic involvement (unilateral versus bilateral).
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.
- Conditions
- Surgery, Cardiac
- Being tested
- Usual physical therapy, Contract-Relax technique
- Keywords
- Respiratory complications, Diaphragmatic paresis, Contract-Relax technique, Ultrasound measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual physical therapyProcedure or surgery
Standard rehabilitation for diaphragmatic paresis
- EFA (Expiratory Flow Acceleration) at the upper thoracic level.
- PEP (Positive Expiratory Pressure).
- Expectoration if necessary (coughing up and spitting out)
Contract-Relax techniqueProcedure or surgery
The diaphragmatic CR is done in a semi-sitting position.
The CR is composed of 4 steps :
- First maximum inspiration expiration with position of the hands of the physiotherapist on the last ribs and without resistance (Goal: taking rhythm).
- Second maximum inspiration expiration : Free inspiration, expiration with pressure on the last ribs to bring the diaphragm into internal stroke.
- Maximum inspiration against resistance, then maximum expiration with increased pressure.
- Maximum inspiration with dynamic release of resistance (Goal: hyperextension of the diaphragm) followed by maximum expiration with resistance to allow an increase in expiratory flow.
| Study group | Role | What they receive |
|---|---|---|
| Usual technique | Active comparator | Standard rehabilitation Receives: Procedure: Usual physical therapy |
| CR technique | Experimental | Standard rehabilitation + 3 CR Receives: Procedure: Usual physical therapy; Procedure: Contract-Relax technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 3 and 5
Secondary outcomes (8)
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).
Measured: 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.
Measured: Days 3, 4 and 5
Non-invasive Ventilation
Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).
Measured: 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.
Measured: from Baseline (Day 0) through Day 30
Incidence of Respiratory Complications
Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.
Measured: from Baseline (Day 0) through Day 30
Intensive Care Unit ICU Length of Stay
Duration of ICU stay (days).
Measured: from Baseline (Day 0) through Day 30
Hospital Length of Stay
Duration of hospitalization (days).
Measured: 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.
Measured: Days 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start25 Nov 2021
- Primary completion21 Oct 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgery, CardiacStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068219
- Sponsor's protocol ID
- 2021/01
- Acronym
- COREDIA
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2021
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No