Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Outcome: Diaphragm atrophy, ventilator-associated diaphragm dysfunction
研究概览
简要总结
Dear participant Participants's patient, who is participants's first-degree relative, who is connected to a ventilator in the intensive care unit, unconscious and not authorized to give informed consent, has been invited to participate in the study titled 'Does transcutaneous phrenic nerve stimulation prevent diaphragm atrophy?
In order to strengthen this muscle and prevent loss of function, investigator provide electrical stimulation between the rib cage and abdomen through the skin with the tens device, causing the muscle to contract and enabling our patient to leave the respirator early.
Investigator aimed to investigate the protective effect of the tens device on the diaphragm by evaluating the diaphragm muscle with the ultrasonography device during the period when it is connected to the respirator. For this reason, the diaphragm will be contracted by giving electrical stimulation three times a day for 30 minutes with the tens device for 5 days during the period when participants's patient is connected to the respirator, and intermittent diaphragm ultrasound will be evaluated.
Participants or participants's legal guardian are asked to approve the use of participants's medical records during participants's treatment in the intensive care unit, provided that participants's personal information is kept confidential. Participants will not incur any financial burden by participating in the study and participants will not receive any additional payment.
Participants are free to leave the study at any time if deemed necessary, and the researcher can terminate the study if deemed necessary. The information obtained within the scope of the research can be used for scientific purposes and can be presented and published provided that the confidentiality record is respected.
I have read (or orally listened to) the text above, which contains the information given to the participants before the research began. I agree to participate in the study as a Volunteer. I consent to the use of my medical information. I also understand that if I do not agree to participate in the study, my treatment will be carried out in full without interruption.
Participant name and surname:
Participant's relative's name and surname:
Degree of closeness:
Signature / Date:
详细描述
In our study, investigator will investigate the effects of early and late trancutaneous phrenic nerve cytimulation on the prevention of diaphragm atrophy in invasive mechanical ventilation patients (>72 hours MV requirement).
Material and Methods of the Study Our study was planned as prospective, single-center, observational. As a result of the power analysis investigator performed for our study, the minimum sample size was calculated as 40 people for each group and 80 people in total with a 90% confidence interval.
Our study will be conducted as specified in the 1995 Declaration of Helsinki
The patients admitted to the Intensive Care Unit of the Anesthesia and Reanimation Clinic of the University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital Anesthesia and Reanimation Clinic Intensive Care Unit between February 1, 2024 and February 1, 2025, the effects of early and late transcutaneous phrenic nerve cytimulation on the diaphragm, diaphragmatic ultrasound and the patient's data registered in the Metavision /QlinICU Clinical Decision Support Software System will be obtained by Structured Query Language (SQL) queries. Vital parameters, hemodynamic, ventilator parameters, laboratory and demographic data will be extracted from the data pool.
Demographic data, biochemical parameters, comorbidities, indications for intubation, duration of invasive mechanical ventilation, respiratory rate, saturation, tidal volume, compliance, FiO2, Peep, above Peep, weaning criteria, peak heart rate, systolic & diastolic blood pressure, Mean arterial pressure, nutritional assessment, balance status, sedation status, length of ICU and hospital stay, and SOFA, APACHI II, Charlson comorbidity Index (CCI) and Ramsey sedation scores will be extracted from the electronic data system to homogenize the groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on invasive mechanical ventilation for 72 hours or more Patients older than 18 years
排除标准
- •Patients under 18 years of age
- •Patients with less than 72 hours of mechanical ventilation
- •Pregnancy
- •Patients with a body mass index above 35kg/m²
- •Neuromuscular disease
- •Refractory epilepsy
- •Patients with pacemakers
- •Unilateral or bilateral diaphragm paralysis
- •Presence of pneumothorax
- •Patients with large right pleural effusion
- •Tracheostomized patients
- •Patients undergoing upper abdominal surgery
结局指标
主要结局
Primary Outcome: Diaphragm atrophy, ventilator-associated diaphragm dysfunction
时间窗: January 22 2024-April 22 2025
By performing phrenic nerve stimulation with TEDS device, the thickness change in the diaphragm muscle will be measured by usg at the end of 5 days. The thickness of the diaphragm muscle will be measured in inspiratory and expiratory. Atrophy will be determined according to the change in thickness. Diaphragm thickening fraction will be calculated by formilizing the thickness in inspiratory and expiratory and diaphragm dysfunction will be determined.DTF (End-inspiratory thickness - End-expiratory thickness)/ End-expiratory thickness)x100. The following values will be accepted for the results. Diaphragmatic Atrophy: Diaphragm thickness\<1-1.5cm Diaphragmatic thickness decreased by 10% compared to baseline Diaphragmatic Dysfunction: Diaphragmatic Thickening Fraction \<20
次要结局
- 1.Duration of Mechanical Ventilation 2.Length of Stay in Intensive Care Unit(January 22 2024-April 22 2025)
研究者
Safiye Tuba Kaplan
Doctor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital