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CTRI Number  CTRI/2021/06/033997 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to evaluate the significance of Rapid Shallow Breathing Index Rate At Extubation for Patient undergoing general anaesthesia. 
Scientific Title of Study   Prospective observational study to evaluate the significance of rapid shallow breathing index rate at extubation for patient undergoing general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pramila S Kurkal 
Designation  Consultant Anesthesiologist 
Affiliation  P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai  
Address  Department of Anesthesia third floor operation theater complex P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9833414451  
Fax    
Email  pskurkal9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramila S Kurkal 
Designation  Consultant Anesthesiologist 
Affiliation  P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai  
Address  Department of Anesthesia third floor operation theater complex P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9833414451  
Fax    
Email  pskurkal9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pramila S Kurkal 
Designation  Consultant Anesthesiologist 
Affiliation  P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai  
Address  Department of Anesthesia third floor operation theater complex P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9833414451  
Fax    
Email  pskurkal9@gmail.com  
 
Source of Monetary or Material Support  
PDHinduja hospital and Medical Research Center, Veer Sawarkar Marg Mahim west Mumbai 400016 
 
Primary Sponsor  
Name  Dr Pramila S Kurkal 
Address  P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Mag Mahim west Mumbai 400016 
Type of Sponsor  Research institution and hospital 
 
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 Darshan P Gopani  P.D.Hinduja hospital and Medical Research Center   Department of Anesthesia third & fourth floor operation theater complex P.D.Hinduja hospital and Medical Research Center Veer Sawarkar Marg Mahim West Mumbai
Mumbai
MAHARASHTRA 
9978677919

darshangopani111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee P.D.Hinduja Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA grade 1 and 2 patients
2. Age group from 18 to 65 years
3. Both sexes
4. Patients willing to be a part of study
 
 
ExclusionCriteria 
Details  1. Airway disease
1.1 obstructive lung disease
1.2 restrictive lung disease
3. Cardio thoracic vascular surgery.
4. History of neurological problems like cerebrovascular accident, head injury, spine injuries.
6. Neurodegenerative disorders, neuromuscular disorders.
7. Patient on psychotropic drugs
8. Chronic smoker
9. Major abdominal surgery, lung surgery
10. Obstructive sleep pane
11. Refusal to be a part of the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1)sequential rapid shallow breathing index at every minute and at extubation
2)Rapid shallow breathing index rate 
1)sequential rapid shallow breathing index at every minute and at extubation
2)Rapid shallow breathing index rate 
 
Secondary Outcome  
Outcome  TimePoints 
Time lapse from reversal to extubation  30 minutes 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/06/2021 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Intubation and extubation are the main concerns of anaesthetist. The process of successful post anaesthesia extubation is a great challenge for the anaesthesiologist working in the operation theater. As an anesthesiologist when we are extubating the surgical patient, three things we keep in our mind (make sure that are fulfilled).1st is patient respiratory muscle power is back to normal so that he can breathe independently without any aid. This is done by normal extubation criteria which are subjective like lifting the head, moving all four limbs etc. and its indirectly indicate that respiratory muscle power is also back to normal. 2nd wakefulness, obeying command, answering by nodding the head, Ramsey sedation score. 3rd hemodynamic stability. All the above three criteria have to be fulfilled before extubation.  Despite several advances in the care of post anaesthesia extubation, failed extubation remains a significant problem faced by the anaesthesiologist that may result into poor patient outcomes. Concerns have been highlighted by different airway societies in their guidelines. Extubation concerns have been well emphasized in the American society of anaesthesiologist closed claims analysis and national audit project 4 (NAP4). The NAP4 report studied the airway-related issues and observed a mortality rate of 5% in patients with extubation failure after general anaesthesia. They reported an incidence of 13% for severe outcomes after extubation failure.  

Rapid shallow breathing index (RSBI) is a tool that is use in the weaning of mechanical ventilation in intensive care units. The rapid shallow breathing index (RSBI) is defined as the ratio of respiratory frequency to tidal volume in liter (f/VT). And RSBI rate is defined as sum total of [(RSBI1min – RSBIextubation) / RSBI1min] x 100. The cut-off point of RSBI in an Intensive care unit setup is 105. If the cut-off for the patient is more than 105 the patient is not ready for extubation. This fact has been successfully proved well beyond doubt in intensive care setup as a major tool used for weaning the ventilated patient gradually and keeping them independent of any aid for ventilator. Most Of the existing extubation criteria are subjective except train of four ratio (TOF) which is objective. Its already established gold standard in anaesthesia but for that you Need to purchase peripheral nerve stimulator, electrode cost will be incurred by the patient, might be painful manier time as patient is coming out of anaesthesia, extra work for an anesthetist. While the RSBI is an objective, no any extra machine requirement, easy to calculate, cost free, no extra work involved and not painful. We have kept the TOF ratio constant for all our patients at 0.9 which is an optimum point at which reversal is generally considered. After reversal the conventional, time tested, clinical extubation criteria are assessed.  At this time sequential RSBI at every minute and at extubation RSBI is noted based on this rapid shallow breathing index rate will be calculated. And the time lapse between reversal and extubation is also noted. Recent anaesthesia machines easily display tidal volume and the respiratory rate generated by the patient which makes it easy to calculate RSBI. The RSBI is noninvasive, easy to calculate, no additional cost involved and an objective parameter. This can be a very useful additional tool to existing post anaesthesia extubation criteria.

 
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