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

Primary Purpose

Surgery, Cardiac

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual physical therapy
Contract-Relax technique
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery, Cardiac focused on measuring Respiratory complications, Diaphragmatic paresis, Contract-Relax technique, Ultrasound measurement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CMC Ambroise ParéRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual technique

CR technique

Arm Description

Standard rehabilitation

Standard rehabilitation + 3 CR

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2021
Last Updated
November 26, 2021
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT05068219
Brief Title
Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery
Acronym
COREDIA
Official Title
Efficacy of a Contract-Relax Technique in the Physical Therapy Management of Diaphragmatic Paresis After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Cardiac
Keywords
Respiratory complications, Diaphragmatic paresis, Contract-Relax technique, Ultrasound measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual technique
Arm Type
Active Comparator
Arm Description
Standard rehabilitation
Arm Title
CR technique
Arm Type
Experimental
Arm Description
Standard rehabilitation + 3 CR
Intervention Type
Procedure
Intervention Name(s)
Usual physical therapy
Intervention Description
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
Intervention Name(s)
Contract-Relax technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diaphragmatic excursion in maximum inspiration
Description
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).
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Diaphragmatic excursion in normal inspiration
Description
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).
Time Frame
Day 5
Title
Oxygen saturation
Description
SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5.
Time Frame
Day 5
Title
Non-invasive ventilation
Description
Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).
Time Frame
Day 30
Title
Oxygenation
Description
Time of oxygen therapy weaning (hours). The reference time t0 will be the time of postoperative extubation.
Time Frame
Day 30
Title
Incidence of respiratory complications
Description
Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.
Time Frame
Day 30
Title
Intensive care unit ICU length of stay
Description
Duration of ICU stay (days).
Time Frame
Day 30
Title
Hospital length of stay
Description
Duration of hospitalization (days).
Time Frame
Day 30
Title
Pain score : Numeric Rating Scale (NRS)
Description
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.
Time Frame
Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxence BURELLE
Phone
01 46 41 31 26
Ext
+33
Email
maxence.burelle@gmail.com
Facility Information:
Facility Name
CMC Ambroise Paré
City
Neuilly-sur-Seine
State/Province
Ile-de-France
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ESTAGNASIE, MD
Phone
01 46 41 89 71
Ext
33
Email
philippe.estagnasie@wanadoo.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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