跳至主要内容
临床试验/CTRI/2025/04/085216
CTRI/2025/04/085216尚未招募不适用

Evaluation of diaphragmatic thickening fraction for prediction of noninvasive ventilation failure – A prospective, observational study

Satya Kumar Moharana1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2025年5月30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
115
试验地点
1
主要终点
1.To determine if diaphragmatic thickening fraction can be used to predict NIV failure in patients with acute respiratory failure.

研究概览

简要总结

Noninvasive ventilation (NIV) is a commonly used mode of ventilation in critically ill patients in ICU that significantly reduces the work of breathing in patients with acute respiratory failure. Therefore, NIV might be effective in delaying and overall reducing the need for intubation in patients. Although NIV is commonly used it has a high failure rate of 25 – 59% and delay in detecting NIV failure and subsequent intubation can worsen the patient’s prognosis and increases mortality and duration of hospital stay. Therefore, it is necessary to predict NIV failure at an early stage.

Previous studies have demonstrated the prediction of NIV failure based on components like the patient’s vital signs, level of consciousness, and degree of acidosis. This led to the development of a scale that considers heart rate, acidosis, consciousness, oxygenation, and respiratory rate known as the HACOR scale to predict NIV failure which is defined as the need for intubation after NIV intervention. It is a rapid and convenient tool to effectively predict NIV failure in patients with hypoxemic respiratory failure. HACOR score > 5 is very high risk of NIV failure.

Currently there are no tools validated to objectively assess the effort of breathing during administration of NIV. Point of care ultrasound (POCUS) in the field of critical care medicine has received increased attention because of its rapid availability as a bed side tool, non-invasive, safe and lack of harmful radiation. Respiratory effort can be estimated using ultrasound assessment of the diaphragm. Diaphragmatic thickness, Diaphragmatic thickening fraction (DTF) and Diaphragmatic excursion (DE) are three commonly used tools to assess diaphragm function.

Diaphragm thickening fraction (DTF) is defined as the percentage change in diaphragm thickness during inspiration. Diaphragm thickness fraction (DTF) = (thickness at end-inspiration – Thickness at end-expiration)/Thickness at end expiration × 100. The thickening fraction (TF) represents diaphragm inspiratory activity effort.

The use of bedside ultrasound to study the diaphragmatic thickening fraction can help in early prediction of NIV failure and prevent delayed intubation and the poor outcomes associated with it. The diaphragmatic thickening fraction can further be compared along with HACOR scorewhich is a validated tool for prediction of NIV failure to see if diaphragmatic thickening fraction along with HACOR score can predict NIV failure better than HACOR or thickening fraction alone. Most of the studies till date were conducted in either Emergency department or Respiratory ICU and majority studies were done either on COPD patients or COVID -19 patients which decreases generalizability to other patient population in ICU with acute respiratory failure (Pneumonia, Congestive heart failure, post operative etc). Most of the studies measured DTF only at initiation or for the first 1, 2 hours and not over time in a patient admitted in ICU. Most of the studies done were either pilot study, preliminary study or were small sample size of < 50 patients. None of the studies till date have assessed the efficacy of diaphragm thickening fraction in predicting NIV failure and compared it with HACOR score which is a validated tool for predicting NIV failure. It is not known whether diaphragmatic thickening fraction can be a sensitive test to predict NIV failure in ICU patients with acute respiratory failure and if it can be added on to the HACOR score for better prediction of NIV failure as compared to either HACOR alone or diaphragmatic thickness fraction alone. We postulate that serial measurements of DTF can predict early NIV failure and requirement of intubation in critically ill patients admitted to ICU with acute respiratory failure and can be a valuable tool to combine with HACOR for better prediction of NIV outcome.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients age greater than 18 years 2.Patients presented to ICU with acute respiratory failure.

排除标准

  • 1.Patients requiring emergent endotracheal intubation upon ICU admission prior to recruitment.
  • 2.Patients initiated on NIV in emergency department or ward prior to ICU admission 3.Patients with interstitial lung disease 4.Patients with neuromuscular disease 5.Patients with chest wall deformities 6.Pregnant female 7.NIV Intolerance – Patient refusal for NIV because of NIV discomfort 8.Patients previously on NIV / Home BiPAP 9.Patients who have consented for Do not intubate / Do not resuscitate 10.Terminally ill patients 11.Patients electively intubated for a procedure.

结局指标

主要结局

1.To determine if diaphragmatic thickening fraction can be used to predict NIV failure in patients with acute respiratory failure.

时间窗: Assessment will be done till there is NIV success, NIV failure or after 48 hours of treatment with NIV, whichever comes earlier.

次要结局

  • 1. To evaluate diaphragmatic thickening fraction and HACOR score vs HACOR score alone for the prediction of noninvasive ventilation failure in patients with acute respiratory failure.(2. To evaluate diaphragmatic thickening fraction vs HACOR score for the prediction of noninvasive ventilation failure in patients with acute respiratory failure.)

研究者

发起方
Satya Kumar Moharana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Satya Kumar Moharana

St Johns Medical College

研究点 (1)

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