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临床试验/NCT02780765
NCT02780765已完成不适用

Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency

Tata Memorial Hospital0 个研究点目标入组 60 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume

研究概览

简要总结

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured.

Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel and additional suctioning if required.

详细描述

60 post operative patients who are kept intubated overnight & are spontaneously breathing will be selected in Tata Memorial Hospital (TMH), Mumbai. 30 patients will be supplied through humidified oxygen using FISHER & PAYKEL MR 370 Heated Humidifier(HH) & 30 patients through conventional mist nebulizer.

Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. Continuous monitoring of temperature will be done using standard monitor.

The reusable HH will be subjected to disinfection between patients. Sterile water will be used for HH & Mist nebuliser.

The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel.

Based on patient's clinical condition , additional suctioning will be done. Frequency of additional suctioning , reason for suctioning will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
  • Undergoing surgery for head and neck cancer
  • Requiring overnight endotracheal tube & breathing spontaneously

排除标准

  • Patients with major cardiac diseases( coronary artery disease, Valvular diseases)
  • Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis.
  • Smokers(abstinence period less than 3 months)
  • Patient in drugs having sialogogue properties.
  • Patient on drugs having anti-sialogogue properties

研究组 & 干预措施

Heated humidifier group

Experimental

30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.

干预措施: heated humidifier (Device)

Mist humidifier group

Active Comparator

30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel.

干预措施: mist humidifier (Device)

结局指标

主要结局

Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume

时间窗: At baseline just before intubation and 24 hours from time of ICU admission

The bevel end \& Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured \& noted

Assess the Increase in Nurses Work Load

时间窗: At baseline just before intubation and 24 hours from time of ICU admission

Investigators will assess nursing workload by frequency of filling of humidifier chamber.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Vijaya P Patil

professor and Anaesthetist

Tata Memorial Hospital

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