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临床试验/NCT04731532
NCT04731532Unknown不适用

University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital

Bursa Yüksek İhtisas Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Duration of patient waking from the mechanical ventilator

研究概览

简要总结

Inclusion and Exclusion Criteria: Patients aged 18-65 years who are admitted to the investigator's 3rd Stage Intensive Care Unit and are dependent on mechanical ventilation will be included. The study was planned with 80 patients. Those with known chronic illnesses such as renal insufficiency, heart failure, liver failure, diabetes mellitus, hypertension, chronic obstructive pulmonary disease etc.,; patients in intensive care for postoperative follow-up; patients with mechanical ventilation due to chest or abdominal trauma will be excluded from the study.

Patients who meet the study criteria will be evaluated by a physiotherapy and rehabilitation specialist and will be decided to be included in the respiratory physiotherapy program. The patients will be treated by two physiotherapists in the intensive care unit at random. One of the physiotherapists will perform classical respiratory physiotherapy with thoracic vibration and the other will only perform classical respiratory physiotherapy.

Patients' acute physiology and chronic health assessment II (APACHE II) scores, partial oxygen pressure(PaO2) /fraction of inspired oxygen inspired oxygen fraction (FiO2), tidal volume, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels will be recorded daily. These values will be collected in the daily routine of the illness depending on the mechanical ventilation, by recording the already performed operations to follow the patient's clinic. If the duration of the total mechanical ventilation and complications occur, the type and timing of the complications will be examined.

At the end of the study, both physiotherapy methods, APACHE II scores, PaO2 / FiO2 values, tidal volume required, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels, mechanical ventilation duration and complications will be compared statistically.

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 (Participant, Care Provider)

盲法说明

pulmonary department, physical therapy and rehabilitation, anesthesiology and reanimation

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation

排除标准

  • Patients with known chronic disease;
  • Patients in intensive care for postoperative follow-up;
  • Patients with mechanical ventilation due to chest or abdominal trauma

结局指标

主要结局

Duration of patient waking from the mechanical ventilator

时间窗: through study completion, an average of 1 year

hour

Measuring of chronic health assessment II (APACHE II) scores

时间窗: through study completion, an average of 1 year

score

Determination of tidal volume

时间窗: through study completion, an average of 1 year

mmHg

Measuring of minute respiratory rate

时间窗: through study completion, an average of 1 year

counts / minute

Determination of peak air pressure

时间窗: through study completion, an average of 1 year

mmHg

Measuring of blood lactate levels

时间窗: through study completion, an average of 1 year

mmol/L

Determination of mean air pressure

时间窗: through study completion, an average of 1 year

mmHg

次要结局

未报告次要终点

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Seyhan Dülger,MD

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (2)

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