临床试验/CTRI/2025/10/096418

CTRI/2025/10/096418尚未招募3 期

A Comparative Study on Efficacy of High Flow Nasal Cannula Oxygen Therapy versus Conventional Oxygen Therapy in Patients Undergoing Bronchoscopy for Bronchoalveolar Lavage : A Randomized Control Trial

Pondicherry Institute of Medical sciences.1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2025年11月11日最近更新: 2025年10月22日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 102
试验地点: 1
主要终点: To compare the episode of incidence of hypoxia (Spo-90%), between HFNC and COT during bronchoscopy with bronchoalveolar lavage.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

After obtaining ethical committee clearance of Pondicherry Institute of Medical Sciences, study will be done.

It is randomized control study with study population of 102 participants. After obtaining informed and written consent patient will be randomized into two groups by computer generated randomization. Group A, procedure will be done with Convention oxygen therapy with nasal cannula with 1-15l/min , and titrated according to saturation.

Group B, HFNC will be used and patient oxygen flow rate and FiO 2 will be tapered according to the saturation.

Both group vitals , Saturation, heart rate, respiratory rate, blood pressure will be monitored pre, inter and post procedure.

And patient tolerance, comfort and post procedure adverse events will be monitored for 24 hours post procedure.

Any episodes of desaturated , frequency of interupptions, post procedure complications will be monitored.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•All patients age 18 years and above with indications of bronchoscopy for bronchoalveolar lavage.

排除标准

未提供

结局指标

主要结局

To compare the episode of incidence of hypoxia (Spo-90%), between HFNC and COT during bronchoscopy with bronchoalveolar lavage.

时间窗: Pre procedural (Baseline) | Room air Saturation, Heart Rate. | During procedure-At bronchoscopy insertion, mid-procedure(every 5 minutes), at maximum point of saturation if any | At completion of bronchoscopy. | Immediate Post procedure | Early recovery - 30 mins after procedure. | 1 hour post procedure

次要结局

To compare the patient comfort and tolerance levels between two group , to compare the rate of procedure interruptions due to desaturation, to analyze the post bronchoscopy complications in both group.(It is assessed from the start of procedure to 24 hours post procedure.)

研究者

发起方

Pondicherry Institute of Medical sciences.

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

G SARIGA

Pondicherry institute of medical sciences

研究点 (1)

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