| CTRI Number |
CTRI/2026/03/105665 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
disinfection and sterilisation of anaesthetic airway equipment in the elective operation theatre of a tertiary care academic hospital, pre- and post-intervention study |
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Scientific Title of Study
|
disinfection and sterilisation of anaesthetic airway equipment in the elective operation theatre of a tertiary care academic hospital, pre- and post-intervention study |
| Trial Acronym |
IEC-INT/2025/MSC-2548 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK KUMAR |
| Designation |
TECHNICIAN OT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876145364 |
| Fax |
|
| Email |
ABHISKEKPGIMER@YAHOO.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
ABHISHEK KUMAR |
| Designation |
TECHNICIAN OT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876145364 |
| Fax |
|
| Email |
ABHISKEKPGIMER@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
ABHISHEK KUMAR |
| Designation |
TECHNICIAN OT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876145364 |
| Fax |
|
| Email |
ABHISKEKPGIMER@YAHOO.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER |
DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| abhishek kumar |
NEHRU HOSPITAL |
DEPARTMENT OF anaesthesia pgimer chandigarh
Chandigarh
CHANDIGARH |
9876145364
ABHISHEKPGIMER@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MEDICALLY FIT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
This study was conducted as a quality improvement pre- and post-intervention study to assess and enhance disinfection and sterilisation practices for anaesthesia airway equipment.
The study was conducted in the elective operating theatres of Nehru Hospital, with microbiological analysis performed in the Department of Medical Microbiology, Research Block A. The total duration of the study was three months, divided equally into a pre-intervention phase, an intervention phase, and a post-intervention phase, each lasting one month (FIGURE 1).
During both the pre- and post-intervention phases, a total of 48 samples were collected for microbiological culture. Surface swab cultures were obtained from four airway equipment on alternate days, approximately 12 samples per week. Over the course of one month, this approach yielded 48 samples in both phases.
|
|
| ExclusionCriteria |
| Details |
This study was conducted as a quality improvement pre- and post-intervention study to assess and enhance disinfection and sterilisation practices for anaesthesia airway equipment.
The study was conducted in the elective operating theatres of Nehru Hospital, with microbiological analysis performed in the Department of Medical Microbiology, Research Block A. The total duration of the study was three months, divided equally into a pre-intervention phase, an intervention phase, and a post-intervention phase, each lasting one month (FIGURE 1).
During both the pre- and post-intervention phases, a total of 48 samples were collected for microbiological culture. Surface swab cultures were obtained from four airway equipment on alternate days, approximately 12 samples per week. Over the course of one month, this approach yielded 48 samples in both phases.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This pre- and post-intervention study was conducted to evaluate the effectiveness of existing disinfection and sterilisation practices used for airway equipment in elective operating theatres. The study also aimed to identify gaps in routine practices and to assess whether targeted interventions could improve compliance with recommended standards. By comparing practices and outcomes before and after the intervention, the study aimed to improve the overall quality and safety of airway equipment reprocessing, thereby reducing the potential risk of infection transmission.
Objectives
To establish the optimal technique for disinfection and sterilisation of airway equipment, including |
This pre- and post-intervention study was conducted to evaluate the effectiveness of existing disinfection and sterilisation practices used for airway equipment in elective operating theatres. The study also aimed to identify gaps in routine practices and to assess whether targeted interventions could improve compliance with recommended standards. By comparing practices and outcomes before and after the intervention, the study aimed to improve the overall quality and safety of airway equipment reprocessing, thereby reducing the potential risk of infection transmission.
Objectives
To establish the optimal technique for disinfection and sterilisation of airway equipment, including |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the optimal technique for disinfection and sterilisation of airway equipment, including facemasks and laryngoscope blades, in elective operating theatres and assess its efficacy. |
To establish the optimal technique for disinfection and sterilisation of airway equipment, including facemasks and laryngoscope blades, in elective operating theatres and assess its efficacy. |
|
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Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
24/03/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ABHISHEKPGIMER@YAHOO.COM].
- For how long will this data be available start date provided 24-02-2026 and end date provided 24-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO POLICY
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Brief Summary
|
Despite significant advances in antimicrobial agents and modern methods of sterilisation, the effectiveness of disinfection and sterilisation procedures continues to be influenced by several critical factors. These include the type and load of microorganisms present, the nature of the material being disinfected, the concentration and contact time of the chemical agent, and the presence of organic matter.6 A thorough understanding of available disinfectants, sterilisation techniques, and microbial responses to these methods is therefore essential for selecting the most appropriate process for a given clinical application. Disinfection refers to a process that eliminates most disease-producing microorganisms but does not reliably destroy bacterial spores. In the operating theatre (OT) environment, disinfection of anaesthetic equipment is commonly achieved using liquid chemical disinfectants or wet pasteurisation techniques. Sterilisation, in contrast, is a more rigorous process that destroys or eliminates all forms of microbial life, including bacterial spores, thereby achieving an acceptable level of sterility. Commonly employed sterilisation methods include steam under pressure (autoclaving), dry heat, ethylene oxide (ETO) gas, and hydrogen peroxide gas plasma,7 each of which has specific indications based on the heat and moisture sensitivity of the equipment being processed. |