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CTRI Number  CTRI/2024/03/063930 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparison of Manual and Automated Jet ventilator in patients undergoing bronchoscopy for Diagnosis or treatment of Tracheo-bronchial lesions and its correlation to effectiveness of carbon dioxide clearance post procedure 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheejah Selvamani R 
Designation  MD anesthesia resident 
Affiliation  Christian medical college and hospital, vellore 
Address  Department of Anesthesia, Christian medical college And hospital, Ida Scudder road, Vellore
Department of Anaesthesia, CMCH, Ida Scudder road, vellore
Vellore
TAMIL NADU
632004
India 
Phone  8072623578  
Fax    
Email  susheera25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sathish Kumar Dharmalingam 
Designation  Professor  
Affiliation  Christian medical college and hospital, vellore 
Address  Department of Anaesthesia, Christian Medical College and Hospital, Ida Scudder road, vellore
Department of Anaesthesia, CMCH, Ida Scudder road, vellore
Vellore
TAMIL NADU
632004
India 
Phone  6369379259  
Fax    
Email  drsathish78@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sheejah Selvamani R 
Designation  MD anesthesia resident 
Affiliation  Christian medical college and hospital, vellore 
Address  Department of Anaesthesia, Christian Medical College and Hospital, Ida Scudder road, vellore
Department of Anaesthesia, CMCH, Ida Scudder road, vellore

TAMIL NADU
632004
India 
Phone  8072623578  
Fax    
Email  susheera25@gmail.com  
 
Source of Monetary or Material Support  
Christian medical college and hospital 
 
Primary Sponsor  
Name  Sheejah Selvamani R 
Address  Department of anaesthesia , Christian Medical college and Hospital, Ida Scudder road, vellore 632004 
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 
DrSheejah Selvamani  Christian Medical College and hospital  Department of Anaesthesia, Christian Medical College and Hospital, Ida Scudder road, vellore.
Vellore
TAMIL NADU 
8072623578

susheera25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF RESEARCH INSTITUTIONAL REVIEW BOARD (IRB)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Automated Jet ventilation  Pre procedure ABG- Automated high frequency jet ventilation in patients undergoing bronchoscopic intervention for diagnosis or treatment of tracheo bronchial lesions at 0.8 to 1bar pressure - according to patient profile and respiratory rate of 80-100 breaths per minute for the duration of procedure . Followed by post procedure ABG to assess PCO2 at end of procedure Duration of intervention 1.5 hours 
Intervention  Manual Jet ventilation  Pre procedure Room air ABG and Manual jet ventilation in patients undergoing bronchoscopic intervention for diagnosis or treatment of tracheo bronchial lesions, ventilation at 12-14 breaths per minute, for however long the procedure is followed by ABG to assess PCo2 at end of procedure . Duration of Intervention 1.5hours 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1.ASA 4 patients
2. Patients with increased requirement of supplemental oxygen pre operatively
3. Patients with haemodynamic instability’
4. Patients not willing to take part in the study
5. Patients with Interstitial Lung disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hypercarbia in manual versus automated high frequency jet ventilation in patients undergoing excision of tracheo bronchial lesions

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


Variables: Age, Sex, BMI, Arterial blood gas analysis to look at PCo2 and PO2, Spo2 and End tidal Co2
24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of intra op hypoxia, hypotension and pneumothorax in manual versus automated Jet ventilation  24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   20/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

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.

 
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