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NCT Number: NCT05068219

Contract-Relax (CR) Technique in the 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.

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.

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Key information

Conditions

Surgery, Cardiac

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiac surgery under extracorporeal circulation,
  • Postoperative diaphragmatic paresis (Diaphragmatic excursion <25mm),
  • Consent for participation,
  • Affiliation to the social security system

Exclusion criteria

  • 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.

Treatment and study plan

Usual physical therapy

Procedure

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 technique

Procedure

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.

Primary outcomes

  1. Diaphragmatic Excursion in Maximum Inspiration

    Time frame: Days 3 and 5

    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).

Secondary outcomes

  1. Diaphragmatic Excursion in Normal Inspiration

    Time frame: Days 3 and 5

    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).

  2. Oxygen Saturation

    Time frame: Days 3, 4 and 5

    SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5.

  3. Non-invasive Ventilation

    Time frame: from Baseline (Day 0) through Day 30

    Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).

  4. Oxygenation

    Time frame: from Baseline (Day 0) through Day 30

    Time of oxygen therapy weaning (days). The reference time t0 will be the time of postoperative extubation.

  5. Incidence of Respiratory Complications

    Time frame: from Baseline (Day 0) through Day 30

    Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.

  6. Intensive Care Unit ICU Length of Stay

    Time frame: from Baseline (Day 0) through Day 30

    Duration of ICU stay (days).

  7. Hospital Length of Stay

    Time frame: from Baseline (Day 0) through Day 30

    Duration of hospitalization (days).

  8. Pain Score : Numeric Rating Scale (NRS)

    Time frame: Days 3 and 4

    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.

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

Efficacy of a Contract-Relax Technique in the Physical Therapy Management of Diaphragmatic Paresis After Cardiac Surgery

Acronym: COREDIA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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