| 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
|
|
|
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
|
|
|
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. |