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临床试验/NCT06062862
NCT06062862已完成不适用

Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Diaphragmatic excursion

研究概览

简要总结

Acquired pneumonia is a sever medical condition that addressed as life-threatening issue require intensive care. Medical Breather device permits activating and strengthening of both inspiratory and expiratory musculatures; thus, it could be useful for pneumatic patients. The aim of the study is to investigate breather effect on hospital stay in pneumatic patients.

详细描述

Sixty participants diagnosed with acquired pneumonia '30 women, 30 men; selected from chest department of Kasr Alaini Intensive Care Unit (ICU) at Cairo University. They were randomly allocated into equal groups; Group A received respiratory training via incentive spirometer, and traditional chest physiotherapy; and Group B received respiratory training via Breather, and traditional chest physiotherapy. both received 3 session daily/2 weeks. Diaphragmatic excursion, Respiratory Distress Observation Scale, and ICU discharge were assessed pre and post treatment.

Careful recruitment of participants based on the study criteria by both ICU resident and PT consultant. Identified inclusive criteria include conscious both genders aged 30- 40 years old with BMI ranged from 25 to5 29.9 Kg/m2 had an acquired pneumonia with a mild hypoxemia (O2 saturation was 90 - 95%). Aware participants whom cooperated through accurate understand and perform instructions. Excluding patients through identified inclusive criteria that if they had a history of any malignant tumors, hearing impairment or mental disorder, auto-immune diseases, a history of any surgical transplantation, unstable hemodynamics, rib fracture, a history of neuromuscular disease, spinal injuries, or BMI > 30 Kg/m2. Also, patients receiving mechanical ventilation, or whom require MV, but contraindicated for rehabilitation i.e., pulmonary emboli were excluded.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sixty patients of both sexes from intensive care unit, Cairo University Hospitals.
  • Their age ranged from 30 to 40 years old.
  • Their BMI were from 25 - 29.9 Kg/m
  • Their oxygen saturation 90 - 95% (mild hypoxemia) conscious level.

排除标准

  • Patient with a history of any malignant tumors.
  • Patients with hearing impairment or mental disorder.
  • Patients with auto-immune diseases.
  • Patients with a history of any surgical transplantation.
  • Patients with hemo-dynamically unstable patients.
  • Patients with rib fracture.
  • Patients with history of neuromuscular disease.
  • Patients with spinal injuries.
  • Patients with BMI > 30 Kg/m
  • Patients receiving mechanical ventilation.

结局指标

主要结局

Diaphragmatic excursion

时间窗: Pre and post treatment after 2 weeks

measured diaphragmatic movement for each subject by using the Diaphragmatic ultrasound at 3.5-5MHz probe that aimed at midclavicular line under rib cage aiming posterior 3rd of hemi diaphragm.

The National Early Warning Score 2 (NEWS2)

时间窗: Pre and post treatment after 2 weeks

) scoring system for evaluating hospital discharge. It measures six physiological items; respiration and pulse rates, O2 saturation, systolic blood pressure, consciousness level or recent onset confusion, also temperature 9. Each parameter is allocated a score of 0, 1, 2, or 3, elevated values indicate that is far away from normal values. 1. Low risk (aggregate score of 1-4). 2. Low to moderate '3 in a single item' risk. 3. Moderate risk (aggregate score of 5-6). 4. Maximum risk (≥7 value). Critical team of care should perform an emergency assessment, often advice transfer case to a higher dependency unit, and 5. a NEWS2 ≥ 0 i.e., no change, warrants a minimum twice daily check that be a routine monitoring.

Respiratory distress observation scale (RDOS)

时间窗: Pre and post treatment after 2 weeks

evaluate severity and discomfort experienced by patients who are unable to communicate their dyspnea levels during monitoring for palliative sedation therapy . RDOS score of less than 3 indicates that the patient is breathing comfortably, d) an RDOS value ≥3 means respiratory distress that require palliative measures, and e) higher RDOS scores indicate a worsening of the patient's condition.

Body mass index (BMI )

时间窗: Pre and post treatment after 2 weeks

Ranged from 25 to 29.9 Kg/m2.

arterial blood gases (ABG)

时间窗: Pre and post treatment after 2 weeks

* potential of hydrogen( pH )(7.35-7.45). * the partial pressure of carbon dioxide in arterial blood.(PaCO2 )(35-45 mmHg). * Bicarbonate (HCO3)(22-28 meq/L). * arterial oxygen saturation (SaO2) (95-100%). * pH (7.35-7.45). * PaCO2 (35-45 mmHg). * HCO3 (22-28 meq/L). * SaO2 (95-100%). . Sample was taken from the radial artery to measure the following parameters6: 7.35-7.45 PH, 35-45 mmHg PaCO2, 22-28 meq/L HCO3, and 95-100% SaO2.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Ahmed Mousa Galeb

Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Cairo University

研究点 (2)

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