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

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.

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.

Study Overview

• Status: Completed
• Conditions: Surgery, Cardiac
• Intervention / Treatment: Procedure: Usual physical therapy; Procedure: Contract-Relax technique

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual technique; Standard rehabilitation	Procedure: Usual physical therapy; 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)
Experimental: CR technique; Standard rehabilitation + 3 CR	Procedure: Usual physical therapy; 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); Procedure: Contract-Relax technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic excursion in maximum inspiration	Diaphragmatic excursion ratio in maximum inspiration at D3 and D5. These measurements are determined by ultrasound in TM mode at D3 before the first rehabilitation session of the day (M1max, displacement, mm) and at D5 before the first rehabilitation session of the day (M2max, displacement, mm).	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic excursion in normal inspiration	Diaphragmatic excursion ratio in normal inspiration at D3 and D5. These measurements are determined by TM ultrasound at D3 before the first rehabilitation session of the day (M1rest, displacement, mm) and at D5 before the first rehabilitation session of the day (M2rest, displacement, mm).	Day 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.	Day 5
Non-invasive ventilation	Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).	Day 30
Oxygenation	Time of oxygen therapy weaning (hours). The reference time t0 will be the time of postoperative extubation.	Day 30
Incidence of respiratory complications	Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.	Day 30
Intensive care unit ICU length of stay	Duration of ICU stay (days).	Day 30
Hospital length of stay	Duration of hospitalization (days).	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.	Day 4

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): October 21, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory complications; Diaphragmatic paresis; Contract-Relax technique; Ultrasound measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: 2021/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No