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

Surgery, Cardiac Clinical Trial

— COREDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068219
• Other study ID #: 2021/01
• Status: Completed
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: November 13, 2023

Study information

• Verified date: December 2023
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 13, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Surgery, Cardiac

Intervention

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)
• 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.

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Non-invasive ventilation	Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).	Day 30
Secondary	Oxygenation	Time of oxygen therapy weaning (hours). The reference time t0 will be the time of postoperative extubation.	Day 30
Secondary	Incidence of respiratory complications	Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.	Day 30
Secondary	Intensive care unit ICU length of stay	Duration of ICU stay (days).	Day 30
Secondary	Hospital length of stay	Duration of hospitalization (days).	Day 30
Secondary	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