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临床试验/CTRI/2023/08/056107
CTRI/2023/08/056107尚未招募4 期

Efficacy Of High Flow Nasal CannulaOxygenation Versus Apnoeic OxygenationIn Patients Undergoing RigidBronchoscopy - A Prospective RandomizedControl Study

Baroda Medical College1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
incidence & the time to desaturate to less then 92 percent peripheral oxygen saturation for more than 10 seconds

研究概览

简要总结

TITLE:

EFFICACY OF HIGH FLOW NASAL CANNULA OXYGENATION VERSUS APNOEIC OXYGENATION IN PATIENTS UNDERGOING RIGID BRONCHOSCOPY - A PROSPECTIVE RANDOMIZED CONTROL STUDY

AIMS & OBJECTIVES:

Our goal is to compare the efficacy of High Flow Nasal Cannula with other methods of apnoeic oxygenation in patients undergoing rigid bronchoscopy to provide a better mode of oxygenation and to prevent hypoxia and the adverse effects related to it.

Primary Objectives: 1. Incidence and the time to desaturate to an Spo2 <92% for more than 10 seconds Secondary Objectives: 1. Incidence of hypercarbia post procedure by monitoring EtCO2 levels 2. EtO2 levels post procedure 3. Number of interruptions during the procedure due to fall in SpO2 4. Severe complications (SpO2< 80%, systolic blood pressure <80 mmHg or vasopressor initiation)

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MATERIALS AND METHODS:

110 patients belonging to age group between 18-60 years of both genders who are scheduled to undergo elective or emergency rigid bronchoscopy are randomised into 2 groups

GROUP H ï‚· In this group, patients will be given apnoeic oxygenation via High Flow Nasal Cannula with heated humidified oxygen at 37 degrees Celsius at an FiO2 of 100% at a flow rate of 30L/minute after the patient has been induced and bronchoscopy procedure has begun. GROUP A ï‚· In this group, patients will be given apnoeic oxygenation via the side port of bronchoscope with oxygen at an FiO2 of 100% at a flow rate of 6L/minute after the patient has been induced and bronchoscopy procedure has begun.

Patient will be premedicated before the procedure and baseline vital parameters such as blood pressure, pulse rate, peripheral oxygen saturation, EtCO2, EtO2 will be noted and both the groups will be preoxygenated using bag and mask with 100% oxygen at 10L/min for 3 minutes . Following the onset of apnoea after giving induction agents different methods of apnoeic oxygenation will be employed as mentioned above. The pulse rate , blood pressure and the peripheral oxygen saturation will be monitored throughout the procedure every minute and bag mask ventilation will be done if the SpO2 falls below 92%. once the procedure is over bag and mask ventilation is done until the patient regains spontaneous respiration and the EtCO2 and EtO2 immediately and 5, 10 mins post procedure will be noted .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • •Patients undergoing elective/emergency Rigid Bronchoscopy Age
  • •60 years of either Gender BMI <30 kg/m2 Patients conformed to ASA 2, 3.

排除标准

  • •Inability or refusal to follow the study protocol.
  • •Patients with tracheostomy tube in situ, intubated patients.
  • •Patients with severe lung disease, hepatic and renal, cardiac dysfunction.
  • •Patients in hypotension and shock.

结局指标

主要结局

incidence & the time to desaturate to less then 92 percent peripheral oxygen saturation for more than 10 seconds

时间窗: incidence & the time to desaturate to less then 92 percent peripheral oxygen saturation for more than 10 seconds

次要结局

  • Incidence of hypercarbia post procedure by monitoring(EtCO2 levels)

研究者

发起方
Baroda Medical College
申办方类型
Government medical college

研究点 (1)

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