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临床试验/CTRI/2024/11/077146
CTRI/2024/11/077146尚未招募不适用

Study of Respiratory Mechanics using Ultrasound in Acute Respiratory Failure before and after Non-Invasive Ventilation

Dr Ashish Gupta1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年12月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
65
试验地点
1
主要终点
Changes in lung ultrasound score, diaphragm excursion, diaphragm thickening fraction, parasternal intercostal muscle thickening fraction, and expiratory abdominal muscle thickening fraction after institution of NIV. Association of these parameters with NIV failure.

研究概览

简要总结

Study title: Study of Respiratory Mechanics using Ultrasound in Acute Respiratory Failure before and after Non-Invasive Ventilation

Study Aim: The aim is to study the respiratory mechanics using ultrasound in patients with Acute Respiratory Failure before and after institution of Non-Invasive Ventilation.

Study Design: Prospective, observational single centre study

Study Area: Intensive Care Unit, Artemis Hospitals, Gurgaon; a tertiary care centre

Study Duration: 18 months

Sample size: 65 patients

Inclusion criteria: Patients admitted in Intensive Care Unit (ICU) with acute respiratory failure (PaO2/FiO2 <300), including Type I Respiratory Failure, Type II Respiratory Failure and patients with increased work of breathing, and scheduled for Non-invasive ventilation (NIV) trial.

Exclusion criteria: Patient refusal, Age less than 18 years, all contraindications to NIV, Non-compliance to NIV, patients on domiciliary NIV support, patients with chest wall deformity, patients with recent history of chest or abdominal surgery (within 1 month), any structural change in chest and abdomen ultrasound which confound the ultrasound parameters, poor echogenic window, obesity (BMI> 35kg/m2), pregnant patients, patients with pre-existing Diaphragm paralysis, patients with pre-existing Neuromuscular disorders, patients with history of diaphragm surgery, patients who refused for invasive mechanical ventilation, and patients requiring planed intubation for any procedure or surgery.

Parameters to be measured: Respiratory parameters (respiratory rate, use of accessory muscles), Hemodynamic parameters (Heart rate, Blood pressure, Oxygen saturation), Arterial blood analysis parameters (partial pressure of oxygen-PaO2, partial pressure of carbon dioxide-PaCO2, fraction of inspired oxygen-FiO2, bicarbonate levels, PaO2/FiO2 ratio), Ultrasound parameters (lung ultrasound score, diaphragm excursion, diaphragm thickening fraction, parasternal intercostal muscle thickening fraction, and expiratory abdominal muscle thickening fraction), and Ventilator parameters (FiO2, PEEP, PS over PEEP,  Ppeak) at baseline, and at 6,12,24,48 hours.

Outcome measures: Changes in lung ultrasound score, diaphragm excursion, diaphragm thickening fraction, parasternal intercostal muscle thickening fraction, and expiratory abdominal muscle thickening fraction after institution of NIV. Association of these parameters with NIV failure, ICU stay duration, hospital stay duration and ICU & in-hospital mortality.

Statistical analysis: The data will be entered in Microsoft Excel and statistical analysis will be done using Statistical Package for Social Sciences (SPSS) software version version 23 (IBM Corp.). Appropriate statistical tests will be applied according to the nature of the data. P value <0.05 will be considered as statistically significant

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted in Intensive Care Unit (ICU) with
  • Acute respiratory failure
  • PaO2/FiO2 less than 300
  • Including Type I Respiratory Failure, Type II Respiratory Failure and patients with increased work of breathing, and
  • scheduled for NIV trial.

排除标准

  • Patient refusal
  • Age less than 18 years
  • All contraindications to NIV
  • Non-compliance to NIV
  • Patients on domiciliary NIV support
  • Patients with chest wall deformity
  • Patients with recent history of chest or abdominal surgery (within 1 month)
  • Any structural change in chest and abdomen ultrasound which confound the ultrasound parameters
  • Poor echogenic window
  • Pregnant patients
  • Patients with pre-existing Diaphragm paralysis
  • Patients with pre-existing Neuromuscular disorders
  • Patients with history of diaphragm surgery
  • Patients who refused for invasive mechanical ventilation
  • Patients requiring planed intubation for any procedure or surgery.

结局指标

主要结局

Changes in lung ultrasound score, diaphragm excursion, diaphragm thickening fraction, parasternal intercostal muscle thickening fraction, and expiratory abdominal muscle thickening fraction after institution of NIV. Association of these parameters with NIV failure.

时间窗: Baseline | 6,12,24,48 hours after initiation on NIV

次要结局

  • Association of above mentioned ultrasound parameters with ICU stay duration, hospital stay duration and ICU and in-hospital mortality.(Baseline)

研究者

发起方
Dr Ashish Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashish Gupta

Artemis Hospitals Gurugram

研究点 (1)

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