FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/011659 [Registered on: 02/02/2018] Trial Registered Retrospectively
Last Modified On: 27/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   comparison of the after effects of tracheostomy on intubated and non intubated patients 
Scientific Title of Study   A CLINICAL STUDY OF THE EFFECT OF TRACHEOSTOMY ON TRACHEOBRONCHIAL TREE AND LUNGS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VIKRAM BHAT K 
Designation  Professor and Unit Chief-MS DNB MNAMS PhD(ENT) 
Affiliation  Professor,Department of ENT, Karnataka Institute of Medical Sciences 
Address  PROFESSOR AND UNIT CHIEF, DEPARTMENT OF ENT, KARNATAKA INSTITUTE OF MEDICAL SCIENCE, HUBLI,KARNATAKA

Dharwad
KARNATAKA
580021
India 
Phone  7899610213  
Fax    
Email  vikram.ent@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VIKRAM BHAT K 
Designation  Professor and Unit Chief- MS DNB MNAMS PhD(ENT) 
Affiliation  Professor, Karnataka Institute of Medical Sciences 
Address  PROFESSOR AND UNIT CHIEF, DEPARTMENT OF ENT, KARNATAKA INSTITUTE OF MEDICAL SCIENCE, HUBLI,KARNATAKA.

Dharwad
KARNATAKA
580021
India 
Phone  7899610213  
Fax    
Email  vikram.ent@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ROSHNA RAJ V RAJAN 
Designation  MBBS, MS(ENT) 
Affiliation  PG(MS), KARNATAKA INSTITUTE OF MEDICAL SCIENCES 
Address  THIRD YEAR MS, DEPARTMENT OF ENT, KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI,KARNATAKA.

Dharwad
KARNATAKA
580021
India 
Phone  9449048423  
Fax    
Email  roshnaraj999@gmail.com  
 
Source of Monetary or Material Support  
Department of ENT and Head and Neck Surgery, Karnataka institute of medical sciences, Hubli, Karnataka. Pincode-580021. 
 
Primary Sponsor  
Name  K F KAMMAR 
Address  Principal Karnataka Institute of Medical Sciences, Vidya Nagar Hubli, Karnataka, India. PINCODE 580022 Mob No:9448435880 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VIKRAM BHAT K  KARNATAKA INSTITUTE OF MEDICAL SCIENCES  NT B UNIT DEPARTMENT OF ENT OPD NUMBER 60
Dharwad
KARNATAKA 		 7899610213

vikram.ent@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS WITH TRACHEOSTOMY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INTUBATED PATIENTS  Intubated patients admitted in the MICU/SICU who underwent tracheostomy were included in the group.  
Comparator Agent  NON INTUBATED PATIENTS  Non-intubated patients with respiratory distress who underwent tracheostomy were included in this group. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.All patients undergoing tracheostomy both paediatric and adult patients. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the after effects of tracheostomy in intubated and non-intubated cases with respect to the following parameters:
1 The secretions from stoma.
2 The flora of the secretions.
3 The chest pathology-tracheobronchial tree and parenchyma. 		 Two assessment follow-ups during:
1 First month
2 Third month 
 
Secondary Outcome  
Outcome  TimePoints 
To study the complications of tracheostomy in intubated and non-intubated cases.   Two assessment followups during post
intervention period
1.one month
2. three month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2015 
Date of Study Completion (India) 30/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOT PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.

 
Close