跳至主要内容
临床试验/CTRI/2024/12/077664
CTRI/2024/12/077664已完成Unknown

A Comparative Study of PranNiti and Standard Oxygen Therapy in Post- Extubation Patients with Type I Respiratory Failure

PGIMER1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
PGIMER
入组人数
100
试验地点
1
主要终点
Absolute changes in arterial partial pressure of oxygen (PaO2)

研究概览

简要总结

Currently available oxygen delivery devices have many shortcomings, factors such as mouth breathing or improper fit can result in inconsistent oxygen delivery, compromising therapy effectiveness. Also, ill-fitting of face masks and nasal cannula can leads to leakage of high concentrations of oxygen in the environment resulting in wastage of an important resource

, environmental pollution, with associated increased risk of causing fire hazards. Subjective errors of not setting the flows while the equipment is in place whereas other situations of not proper placing of the equipment while the flows are on, not full filling the purpose. There is no inbuilt safety mechanism for detecting apnea and thus supply of oxygen continues even if the patient is not breathing. High flows rates are required to produce high fiO2 resulting in dryness of nose and oral cavity leading to patient discomfort.

Addressing these concerns, an innovative and patented oxygen delivery device called PranNiti, is a great O2 conserving tool. The device is registered under FDA (Food and Drug Administration, Pune, Maharashtra division) with License no. MFG/MD/2023/001075. This is noninvasive oxygen supplementing device with required patient safety features. On initial trials it was proven to be able to give oxygen savings up to 70 % achieving better SPO2.

Hence, the present study will be carried out in the post extubation patients with type 1 respiratory failure comparing the efficacy of the standard oxygen delivery device-Venturi mask with PranNiti. This study aims to provide evidence-based recommendations for optimizing oxygen therapy in post-extubation patients with type 1 respiratory failure. By comparing standard oxygen delivery devices with a newly developed device, this research has the potential to improve patient outcomes, enhance healthcare resource utilization, and guide clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Type 1 respiratory failure Spo2 less than 96 respiratory rate less than 30.

排除标准

  • Patients with baseline spo2 greater than 96 Parturient refusal to consent Severe Respiratory failure with Spo2 less than 85 RR more than30 Clinically significant respiratory distress, for example retractions, grunting, cyanosis, possible Co2 narcosis.
  • severe comorbidities like severe heart failure, pregnancy, etc.
  • nasal injury, emphysematous bullae, severe valvular heart disease, cyanotic heart disease and nasal surgery.

结局指标

主要结局

Absolute changes in arterial partial pressure of oxygen (PaO2)

时间窗: 30 minutes after initiation of oxygen therapy.

次要结局

  • SpO2(Cerebral and somatic oxygenation)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ashish Singh Aditya

Post Graduate Institute of Medical Education & Research (PGIMER)

研究点 (1)

Loading locations...

相似试验