Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery

NCT05068219 | Completed Results

• 1 other identifier: 2021/01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgery, Cardiac

Keywords

Respiratory complications; Diaphragmatic paresis; Contract-Relax technique; Ultrasound measurement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Diaphragmatic Excursion in Normal Inspiration

  Days 3 and 5

• Oxygen Saturation

  Days 3, 4 and 5

• Non-invasive Ventilation

  from Baseline (Day 0) through Day 30

• Oxygenation

  from Baseline (Day 0) through Day 30

• Incidence of Respiratory Complications

  from Baseline (Day 0) through Day 30

Study Arms (2)

Usual technique

ACTIVE COMPARATOR

Standard rehabilitation

Procedure: Usual physical therapy

CR technique

EXPERIMENTAL

Standard rehabilitation + 3 CR

Procedure: Usual physical therapy; Procedure: Contract-Relax technique

Interventions

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)

CR technique; Usual technique

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.

CR technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

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

Location

Results Point of Contact

• Title: Maxence BURELLE
• Organization: CMC Ambroise Paré Hartmann

recherche@clinique-a-pare.fr

01 46 41 31 26

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 5, 2021
• Study Start: November 25, 2021
• Primary Completion: October 21, 2023
• Study Completion: November 13, 2023
• Last Updated: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)