| CTRI Number |
CTRI/2024/03/064296 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
how the height of the operating table affects the ability to properly insert a breathing device (supraglottic airway device) in children having surgery while under general anesthesia. |
|
Scientific Title of Study
|
Effect of Different Operating Table Height on Successful Insertion of Supraglottic Airway Device in Pediatric Patients Undergoing Elective Surgery Under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Touseef Khan |
| Designation |
PG Anaesthesia |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital
New Delhi DELHI 110001 India |
| Phone |
9013234450 |
| Fax |
|
| Email |
nickkhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti Singh |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital
New Delhi DELHI 110001 India |
| Phone |
9910241887 |
| Fax |
|
| Email |
drjyoti.md@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyoti Singh |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital
DELHI 110001 India |
| Phone |
9910241887 |
| Fax |
|
| Email |
drjyoti.md@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS Dr RML hospital
Baba Kharaksingh Marg, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML hospital |
| Address |
Baba kharak Singh mark, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Touseef Khan |
ABVIMS and Dr RML Hospital, New Delhi |
Room no.304, 3rd floor, department of Anaesthesiology, PGI building,Dr RML Hospital, Baba kharak Singh Marg, New Delhi 110001 New Delhi DELHI |
9013234450
nickkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.RML hospital,New Delhi ethics committee |
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 |
| Comparator Agent |
Comparing ease of insertion of supraglottic airway device at different level of table heights |
After informed consent patient will be taken in OT standard monitors will be attached. After securing IV line patient will be induced. Patients will be divided in two groups one at the level of umbilicus and the parameters will be compared with second group from 0 minute to 5 minute. |
| Comparator Agent |
comparing the ease of insertion of supraglottic airway device at different table heights |
After informed consent patient will be taken in OT standard monitors will be attached. After securing IV line patient will be induced. Patients will be divided in two groups in second group at the level of anterior superior iliac spine and ease of insertion of supraglottic airway device will be compared with first group from 0 minute to 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 AND 2
|
|
| ExclusionCriteria |
| Details |
Trauma, Tumor or deformity of upper airway
Patient with thyroid and neck swelling
Fracture and deformity of cervical spine
Past history of difficult intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Appearance of EtCO2 waveform on capnography.
delivery of set tidal volume
successful gastric tube insertion through gastric port of supraglottic airway device |
0 minute, 3 minute and 5 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The duration of Insertion which will be measured from the placement of SAD at oral orifice to the appearance of EtCO2 waveform. |
0 second 30 seconds & 1 minute |
|
|
Target Sample Size
|
Total Sample Size="182" Sample Size from India="182"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="5" 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
|
General anaesthesia is a state of deep sleep or unconsciousness, during which the patient has no awareness or sensation. Airway management is a crucial period during the administration of general anaesthesia. One of the ways of maintenance of airway involves placement of a supraglottic airway device that sits above the vocal cords, which allows for adequate delivery of oxygen and anaesthetic gases to lungs. Supra Glottic Airway devices have become a standard management, filling a niche between the face mask and tracheal tube in terms of both anatomical position and degree of invasiveness. 2nd generation supraglottic airway device with gastric port stands out as the latest, most intricate, and potentially, the most impactful among specialized laryngeal mask devices. The primary objective in its design was to create a laryngeal mask with enhanced ventilatory properties while also offering safeguards against regurgitation and gastric insufflation. The key innovations include a modified cuff and a drainage tube. 2nd generation supraglottic airway device functions as a double mask, establishing two end-to-end connections: one with the respiratory tract and the other with the gastrointestinal tract. 2nd generation supraglottic airway device wit gastric port is used commonly as it provides numerous advantages when compared to endotracheal intubation, including superior haemodynamic stability, less airway trauma, superior patients comfort, and offers protection from barotrauma with smooth awakening of the patient.1 The success rate of SAD insertion ranges from 77% to 90%, and suboptimal positioning occurs in 30–66% of cases.2 Airway morbidity still occurs even with the apparent proper insertion of SAD3. As such, the SAD should be inserted and placed in an optimal position to minimize complications and allow for maximal functionality. Operating table height can influence task performance and physical/mental workload of anaesthesiologist 4. The physical effort required for bag and mask ventilation and endotracheal intubation is influenced by the positioning of the patient and the height of the operating table. This positioning relies on maintaining an unobstructed linear path between the larynx and the observer’s eye. Achieving this necessitates precise patient positioning, which, in turn, depends on employing various maneuvers and adjusting the height of the operating table. Incorrect body posture can have detrimental effects on the health of an anaesthetist, potentially leading to back problems. Children have been the earliest patrons of anaesthesiology from its earliest clinical applications of surgical anaesthesia. SAD is widely used in pediatric anaesthesia to maintain airway during surgery. To the best of our knowledge, no similar study was conducted on investigating the optimal table height for SAD placement in pediatric population. So, we propose a study to compare two operating table heights to find out which could allow for a successful insertion of SAD at the first attempt in pediatric population. |