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临床试验/CTRI/2024/03/063930
CTRI/2024/03/063930尚未招募1 期

Manual versus Automated Jet ventilation and incidence of post procedural hypercarbia in Patients undergoing bronchoscopic procedures under anaesthesia for excision of tracheobronchial lesions in a tertiary care hospital - a prospective cohort study

Sheejah Selvamani R1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare the incidence of hypercarbia in manual versus automated high frequency jet ventilation in patients undergoing excision of tracheo bronchial lesions

研究概览

简要总结

Bronchoscopy-both Rigid and Flexible paves way for Diagnostic and therapeutic procedures to be performed in the tracheobronchial tree. These specific procedures form a common work field for both the Anaesthesiologist and the Interventional Pulmonologist involved, it also requires special management of the Airway which is most often already compromised or Vulnerable. Maintaining Spontaneous Ventilation through a compromised or narrow Airway is usually not a practical option and the depth of anaesthesia required to suppress protective airway reflexes also leads to considerable amount of respiratory depression and the introduction of a bronchoscope and other instruments further narrows the available airway thereby adding to the respiratory depression and CO2 retention.

Various methods have been used to maintain Oxygenation during Bronchoscopic procedure depending on the clinical scenario and the duration of Surgery. One such method is Jet ventilation- with its advantage being -the airway is left open for the maneuvering of various tools while simultaneously maintaining adequate gas exchange.

The most common complications associated with Jet ventilation are Hypercapnia, hypoxia and Haemodynamic Instability(1)

The Aim of our study is the compare the incidence of Hypercarbia in patients undergoing diagnostic or therapeutic bronchoscopy in manual and Automated jet ventilator by measuring the post procedure arterial PaCO2 levels, and to compare other parameters such as oxygen Saturation and arterial PaO2 to assess of effectiveness of ventilation in Manual and Jet Ventilation. The Study also aims to document and compare the incidence of Haemodynamic instability in both modes of Ventilation. By the end of our analysis we will be able to arrive at a consensus as to which mode of Jet ventilation is most effective in Preventing Hypercarbia, Hypoxemia and hemodynamic instability and thereby proving to be safer and superior to the other.

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
15.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All ASA 1, ASA 2 and ASA 3 patients undergoing bronchoscopic procedures under Anaesthesia for excision of tracheobronchial lesions and willing to give informed consent and take part in the study.

排除标准

  • 1.ASA 4 patients
  • Patients with increased requirement of supplemental oxygen pre operatively
  • Patients with haemodynamic instability’
  • Patients not willing to take part in the study
  • Patients with Interstitial Lung disease.

结局指标

主要结局

To compare the incidence of hypercarbia in manual versus automated high frequency jet ventilation in patients undergoing excision of tracheo bronchial lesions

时间窗: Variables: Age, Sex, BMI, Arterial blood gas analysis to look at PCo2 and PO2, Spo2 and End tidal Co2 | 24 hours

Variables: Age, Sex, BMI, Arterial blood gas analysis to look at PCo2 and PO2, Spo2 and End tidal Co2

时间窗: Variables: Age, Sex, BMI, Arterial blood gas analysis to look at PCo2 and PO2, Spo2 and End tidal Co2 | 24 hours

次要结局

  • To compare the incidence of intra op hypoxia, hypotension and pneumothorax in manual versus automated Jet ventilation(24 hours)

研究者

发起方
Sheejah Selvamani R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sheejah Selvamani R

Christian medical college and hospital, vellore

研究点 (1)

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