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

NCT ID: NCT05068219

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2023-11-13

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual technique

Standard rehabilitation

Group Type: ACTIVE_COMPARATOR

Usual physical therapy

Intervention Type: 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

Standard rehabilitation + 3 CR

Group Type: EXPERIMENTAL

Usual physical therapy

Intervention Type: 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

Intervention Type: 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.

Interventions

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)

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMC Ambroise Paré

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

Countries

France

Other Identifiers

2021/01

Identifier Type: -

Identifier Source: org_study_id