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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
Intervention / Comparator Agent
|
|
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. |