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CTRI Number  CTRI/2020/07/026610 [Registered on: 15/07/2020] Trial Registered Prospectively
Last Modified On: 20/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   General anaesthesia with aerosol box during COVID pandemic 
Scientific Title of Study   Prospective Study of Intubation Outcomes using the Aerosol Box during the COVID-19 Pandemic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakshi V V 
Designation  Associate Professor 
Affiliation  Cancer Institute, Adyar, Chennai. 
Address  Department of Anaesthesia. Cancer Institute (WIA) Dr S. Krishnamurti Campus, Sardar Patel Road.
Cancer Institute (WIA)
Chennai
TAMIL NADU
600036
India 
Phone  9940370735  
Fax    
Email  meenaram99@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Meenakshi V V 
Designation  Associate Professor 
Affiliation  Cancer Institute, Adyar, Chennai. 
Address  Department of Anaesthesia. Cancer Institute (WIA) Dr S. Krishnamurti Campus, Sardar Patel Road.
Cancer Institute (WIA)

TAMIL NADU
600036
India 
Phone  9940370735  
Fax    
Email  meenaram99@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Meenakshi V V 
Designation  Associate Professor 
Affiliation  Cancer Institute, Adyar, Chennai. 
Address  Department of Anaesthesia. Cancer Institute (WIA) Dr S. Krishnamurti Campus, Sardar Patel Road.
Cancer Institute (WIA)

TAMIL NADU
600036
India 
Phone  9940370735  
Fax    
Email  meenaram99@yahoo.com  
 
Source of Monetary or Material Support  
Cancer Institute (WIA) Dr S Krishnamurthy Campus, Sardar Patel Road Adyar Chennai 20 
 
Primary Sponsor  
Name  Cancer Institute WIA 
Address  Dr. S.Krishnamurthy Campus Sardar Patel Reoad. Adyar Chennai 600020  
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 
DrMeenakshi V V  Cancer Institute (WIA)  Department of Anaesthesia. Cancer Institute WIA Dr S. Krishnamurti Campus, Sardar Patel Road.
Chennai
TAMIL NADU 
9940370735

meenaram99@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age: Patients of both sexes greater than or equal to 18 yrs of age
2.Patients receiving suxamethonium or rocuronium (if allergic to suxamethonium or contraindication to suxamethonium) will be included.
3.Intubations performed by anaesthesiologists who have ≥ 3 years clinical experience following their training will be considered for the study.
4.Anaesthesiologists will use the conventional Macintosh Laryngoscope or the C-Mac Video Laryngoscope depending upon the availability and comfort.
 
 
ExclusionCriteria 
Details  1.Patients requiring awake fiberoptic guided intubation.
2.Patients who cannot fit within the aerosol box due to their body habitus.
3.Patients who are undergoing emergency surgery and are at risk for gastric aspiration.
4.Patients requiring double lumen tube (DLT) insertion
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to intubation- defined as time from when the laryngoscope blade passes between the patients lips until the first upstroke of the capnograph trace   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Airway manipulation time
2.The number of attempts made to intubate.
3.First pass success rate
4.Fall in saturation during the period of intubation to SpO2≤ 90%.
5.Failure to intubate using aerosol box  
24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/07/2020 
Date of Study Completion (India) 04/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Venketeswaran MV, Srinivasaraghavan N, Balakrishnan K, Seshadri RA, Sriman S. Intubation outcomes using the aerosol box during the COVID-19 pandemic: A prospective, observational study. Indian J Anaesth. 2021 Mar;65(3):221-228. doi: 10.4103/ija.IJA_1578_20. Epub 2021 Mar 13. PMID: 33776113; PMCID: PMC7989496. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Tracheal intubation performed during general anaesthesia is an aerosol generating procedure placing the anaesthesia team at risk for contracting corona virus. The aerosol box is a containment device recommended for use and widely being used during intubation to protect the anaesthesia team and the surroundings. There is no scientific study regarding the ease of intubation and problems faced while using the aerosol box as well as patient safety during the intubation process. Hence we are planning to do a prospective study of intubation related outcomes and patient safety during intubation while using the aerosol box. 
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