Efficacy of a Contract-Relax Technique in the Physical Therapy Management of Diaphragmatic Paresis After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Diaphragmatic excursion in maximum inspiration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery under extracorporeal circulation,
- •Postoperative diaphragmatic paresis (Diaphragmatic excursion <25mm),
- •Consent for participation,
- •Affiliation to the social security system
排除标准
- •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.
研究组 & 干预措施
Usual technique
Standard rehabilitation
干预措施: Usual physical therapy (Procedure)
CR technique
Standard rehabilitation + 3 CR
干预措施: Usual physical therapy (Procedure)
CR technique
Standard rehabilitation + 3 CR
干预措施: Contract-Relax technique (Procedure)
结局指标
主要结局
Diaphragmatic excursion in maximum inspiration
时间窗: 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).
次要结局
- Hospital length of stay(Day 30)
- Pain score : Numeric Rating Scale (NRS)(Day 4)
- Diaphragmatic excursion in normal inspiration(Day 5)
- Oxygen saturation(Day 5)
- Non-invasive ventilation(Day 30)
- Intensive care unit ICU length of stay(Day 30)
- Oxygenation(Day 30)
- Incidence of respiratory complications(Day 30)