跳至主要内容
临床试验/NCT06221033
NCT06221033招募中不适用

Manual Hyperinflation Versus Diaphragmatic Proprioceptive Neuromuscular Facilitation on Pulmonary Functions in Mechanically Ventilated Patients

omar hasham mohamed2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
C- reactive protein analysis

研究概览

简要总结

the goal of this clinical trial is to compare between to important physiotherapy modalities applied on mechanically ventilated COPD patients the the main question the study aim to answer is which one of the two modalities has the better effect on mechanically ventilated patients with COPD

patients will get manual hyperinflation technique and PNF technique \

researchers will compare MHI with PNF and will take a control group also

详细描述

In this study, the effects of diaphragmatic proprioceptive neuromuscular facilitation and manual hyperinflation on pulmonary functions in patients on mechanical ventilation will be compared.

The following headings will be used to present the study's subject and methods: patients, tools, study protocols, and statistical techniques.

I. Patients

The trial will involve sixty male patients with AECOPD who are on mechanical ventilation. They will be chosen from the Gamal Abdel Nasser Hospital's intensive care unit at the Health Insurance Organization in Alexandria, Egypt. They will be between the ages of fifty and sixty. Three equal groups will be randomly assigned to the study's patients.

Study Group A (20 patients) will undergo chest physiotherapy and conventional medical treatment in addition to manual hyperinflation technique.

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
None

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients will be included in the study if they have the following criteria:
  • Sixty male mechanically ventilated patients. They will be ventilated on pressure support (PS) mode of MV with this setting (Positive end-expiratory pressure [PEEP]) less than 8 cm H2O, FiO2 0.4 or less, SpO2 higher than 90) due to AECOPD.
  • Their Glasgow Coma Scale score will be ranged from 13 to
  • Their age between 50 and 60 years old.
  • Their BMI will be ranged from 25 to 34.9 kg/m
  • Moderate (GOLD 2) and severe (GOLD 3) stages of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) grading system for the severity of COPD.

排除标准

  • The patients will be excluded from this study if they have one of the following criteria:
  • Fever above 38.3 °C. Unstable hemodynamics. Thoracic or abdominal surgery that preclude the use of PNF exercises. Chest trauma such as rib fracture, flail chest and thoracic vertebra fracture or chest burns.
  • Peripheral and central nervous system diseases. Active lung infection like tuberculosis. Active bleeding as alveolar hemorrhage, hemoptysis. Spinal cord injuries involved the phrenic nerve. Severe cardiac complications due to COPD.

结局指标

主要结局

C- reactive protein analysis

时间窗: immediately after the intervention

Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms. Each patient will be instructed to assume a relaxed comfortable position with loose clothes. Initial step, phlebotomist will secure a snug rubber band around patient's upper arm, and the patient will be asked to pump his fist several times. Then phlebotomist will palpate the vein, and will cleanse with an alcohol prep pad. Then practitioner will introduce a needle into the vein, and will draw a vial of blood. After that the practitioner will remove the band, then remove the needle and apply pressure to venipuncture site up to one minute. A bandage will be applied over the site. The test will be conducted for all patients pre and post the treatment program duration. Normal finding for C-reactive protein (CRP) is \< 1.0 mg/dL or \<10.0 mg/L (SI units) (\< 3 mg/L for high-sensitivity CRP \[hs-CRP\]),

Blood gases analysis

时间窗: immediately after the intervention

Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms. Each patient will be informed to assume a relaxed comfortable position with loose clothes. Arterial blood samples will be taken via arterial line which is accessible and less painful. The collected arterial blood sample will be sent for laboratory investigation according to ICU department laboratory communication protocol of Gamal Abdel Nasser Hospital. The test will be conducted for all patients pre and post the treatment program duration.

Assessment of chest expansion

时间窗: immediately after the intervention

Each patient will be informed about the purpose of the test and how it will be done with keeping the explanation brief and in simple terms. Each patient will assume a comfortable half lying suping position. Marking will be done at 3 levels; axillary, nipple and xiphisterna. Patient will be asked to first take some normal breaths as a breath control technique for relaxation. Then will be asked to exhale completely and then inhale maximally as much as he can and hold breath for a second. The difference between maximum exhalation and inhalation will be recorded during holding breath using a measuring tape at all three-level mentioned above. This procedure will be repeated three times and then the best value will be recorded The chest expansion will be measured for all patients pre and post the treatment program duration

Assessment of weaning parameters

时间窗: during the assessment time

The weaning process will be indicated according to the following criteria; Adequate oxygenation" PaO2/FIO2 ratio ≥ 200, FIO2≤ 0.40, PaO2 ≥ 60, PaCO2 and PEEP ≤ 5 cmH2O", PH ≥ 7.30, Respiratory rate ≤ 45 bpm, Heart rate ≤ 140 bpm, RSBI ≤ 8 breaths/min/ml/kg body weight, Hemodynamic stability" no or minimal vasopressors or inotropes", Appropriate level of conscious, No continuous sedation infusion nor neuromuscular blocking agents, Afebrile, Adequate hemoglobin ≥8 g/dl and/or no evidence of hemorrhage

Oxygenation Index

时间窗: immediately after the intervention

Oxygenation index is the better indicator for defining of lung injury compared to the PaO2/FiO2 ratio as it includes mean airway pressure (MAP), also it is an important determinant of oxygenation of acute respiratory failure, which evaluated according the following equation (PaO2/ FiO2) \<300 mmHg with or without elevated arterial carbon dioxide tension (PaCO2) (Liu et al., 2015). OI is a commonly used to assess the severity of hypoxic respiratory failure (HRF) and persistent pulmonary hypertension OI = mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 . Where FiO2: Fraction of inspired oxygen in percent. MAP: Mean airway pressure in mmHg. FiO2: Fraction of inspired oxygen. PaO2: Partial pressure of oxygen in arterial blood in mmHg. The oxygenation index will be recorded for all patients pre and post the treatment program duration.

次要结局

  • Weaning success rate:(immediately after the intervention)

研究者

发起方
omar hasham mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

omar hasham mohamed

physiotherapist

Cairo University

研究点 (2)

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