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临床试验/CTRI/2018/02/011659
CTRI/2018/02/011659已完成不适用

A CLINICAL STUDY OF THE EFFECT OF TRACHEOSTOMY ON TRACHEOBRONCHIAL TREE AND LUNGS.

K F KAMMAR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To study the after effects of tracheostomy in intubated and non-intubated cases with respect to the following parameters:

研究概览

简要总结

Tracheostomy refers to the surgical creation of a stoma into the trachea through neck to maintain airway. This study concentrates on the effect on tracheostomy on the tracheal secretions in both intubated and non-intubated patients.

The aim was to study the effect of tracheostomy on the organisms on the tracheal secretions, on color,consistency, and quantity of tracheal secretions and the effect on the tracheobronchial tree and lungs.

The study was conducted on a sample size of 60 patients with two groups of 30 each- intubated and non-intubated. The selected patients underwent a few investigations. Detailed examination of patient was performed. The patients after undergoing tracheostomy were examined on Day 2 and follow up was done at first and third month  or as long as the patient lived. During each follow up, patient was assessed concentrating mainly on the tracheal secretions like the color, quantity and consistency along with investigations like culture and sensitivity of tracheal aspirate, and chest X-ray. Patients were also assessed for any complications and documented.

The most common organism cultured on immediate follow up was Pseudomonas and Klebsiella in intubated & non-intubated patients respectively. Almost 90% patients in both groups yielded growth immediately post tracheostomy. The amount of tracheal secretion was profuse immediately after tracheostomy which gradually reduced to scanty during the three months of follow up. The growth pattern in the secretions did not significantly influence the development of chest complications. Intubation prior to tracheostomy was not a significant risk factor for the development of chest complications.

Endotracheal intubation prior to the procedure of open surgical tracheostomy does not significantly make a difference in the quantity and consistency of the tracheal secretion. Tracheal secretions were 90% infective in the immediate post tracheostomy period which became non infective through the first and third month of follow up. Tracheostomy didn’t have any effect on the chest pathology in both intubated and non-intubated patients.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients undergoing tracheostomy both paediatric and adult patients.

排除标准

  • 1.Severely ill patients in ICU with poor prognosis and not fit for investigations.
  • 2.Tracheoesophageal fistula.
  • 3.Patients not willing to be a part of the study.
  • 4.Immunocomprised patients.

结局指标

主要结局

To study the after effects of tracheostomy in intubated and non-intubated cases with respect to the following parameters:

时间窗: Two assessment follow-ups during: | 1 First month | 2 Third month

1 The secretions from stoma.

时间窗: Two assessment follow-ups during: | 1 First month | 2 Third month

2 The flora of the secretions.

时间窗: Two assessment follow-ups during: | 1 First month | 2 Third month

3 The chest pathology-tracheobronchial tree and parenchyma.

时间窗: Two assessment follow-ups during: | 1 First month | 2 Third month

次要结局

  • To study the complications of tracheostomy in intubated and non-intubated cases.(Two assessment followups during post)

研究者

发起方
K F KAMMAR
申办方类型
Other [self]

研究点 (1)

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