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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068219

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery, Cardiac	Procedure: Usual physical therapy Procedure: Contract-Relax technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 25, 2021

Anticipated Primary Completion Date :

Oct 25, 2023

Anticipated Study Completion Date :

Nov 25, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Diaphragmatic excursion in maximum inspiration [Day 5]
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).

Secondary Outcome Measures

Diaphragmatic excursion in normal inspiration [Day 5]
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).
Oxygen saturation [Day 5]
SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5.
Non-invasive ventilation [Day 30]
Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).
Oxygenation [Day 30]
Time of oxygen therapy weaning (hours). The reference time t0 will be the time of postoperative extubation.
Incidence of respiratory complications [Day 30]
Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.
Intensive care unit ICU length of stay [Day 30]
Duration of ICU stay (days).
Hospital length of stay [Day 30]
Duration of hospitalization (days).
Pain score : Numeric Rating Scale (NRS) [Day 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France	France	92200

Sponsors and Collaborators

CMC Ambroise Paré

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CMC Ambroise Paré

ClinicalTrials.gov Identifier:

NCT05068219

Other Study ID Numbers:

2021/01

First Posted:

Oct 5, 2021

Last Update Posted:

Dec 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CMC Ambroise Paré

Respiratory complications

Diaphragmatic paresis

Contract-Relax technique

Ultrasound measurement

Additional relevant MeSH terms:

Muscle Weakness

Paresis

Study Results

No Results Posted as of Dec 9, 2021