| CTRI Number |
CTRI/2024/01/061573 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the efficacy of two different types of airway devices in children undergoing surgery. |
|
Scientific Title of Study
|
Comparison of Performance Characteristics of LMA ProSeal® and LMA BlockBuster® in Children Undergoing Surgical Procedures Under General Anaesthesia: A Randomized Control Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Kumar Kannaujia |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, RaeBareli Road, Lucknow UTTAR PRADESH 226014 India.
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Kumar Kannaujia |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, RaeBareli Road, Lucknow UTTAR PRADESH 226014 India.
UTTAR PRADESH
226014
India |
| Phone |
8765974042 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kolli Ajit Kumar |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Postgraduate Institue of Medical Sciences |
| Address |
Department of Anaesthesiology, First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, RaeBareli Road, Lucknow UTTAR PRADESH 226014 India.
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
7002424426 |
| Fax |
|
| Email |
kolliajitkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road Lucknow, Uttar Pradesh,226014. |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences |
| Address |
Rae Barely Road, Lucknow, Uttar Pradesh, 226014 |
| 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 |
| Dr Ashish Kumar Kannaujia |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Sanjay Gandhi Postgraduate Institue of Medical Sciences.
Department of Anaesthesiology.
Room number 27.
Lucknow
UTTAR PRADESH |
8765974042
ashishkannaujia77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 132nd Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I and II patients.
2)Both male and female patients between 1-12 years of age.
3)Elective procedures under General Anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Parents/Patients attendant not giving consent.
2.Weight less than 5 kg.
3.Patients with BMI > 30 kg/m2.
4.History of recent upper respiratory tract infection.
5.Inadequate fasting.
6.Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.).
7.Patients with abnormal/distorted anatomy of the upper airway.
8.Head, neck and oral surgery.
9.Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.).
10.Emergency surgeries. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure will be measured as the primary outcome. |
Immediately after supraglottic airway device insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
First-attempt and overall success rate of LMA insertion
2. Device insertion time
3. Ease of LMA insertion
4. Leak fraction calculation
5. Fibreoptic scoring of glottic opening
6. Ease of gastric tube insertion
7. Gastric tube insertion time
8. Vitals(SBP/DBP/HR/SPO2)
9. Peak airway pressure
10. Adverse effects: Bloodstain on the device, Hypoxia, Cough, Injury to lips, tongue, Oropharyngeal soft tissue and teeth, Sore throat, Change of voice,Dysphagia |
1. before insertion of LMA(baseline)
2. From the time of touching the device and insertion till appearance of the first capnograph
3. grading ease of insertion
4. immediately after LMA insertion
5. Fibreoptic scope grading will be seen
6. gastric tube insertion will be graded
7. From touching the device till insertion and confirmation
8. At 1,5,10 and 15-minute intervals
9. At 1,5,10 and 15-minute intervals
10. Immediately and till 24hrs postoperative period
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/01/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Airway management is one of the most essential and life-saving skills for an anaesthesiologist. There are several methods for airway management, but laryngoscopy and endotracheal intubation are considered the gold standard for securing the airway, however, it is difficult to learn and retain these skills. To overcome this problem classic Laryngeal mask airway (LMA classic) was introduced in 1983 by Archie Brain.LMA classic had limitations like a moderate pharyngeal seal and risk of regurgitation of gastric contents and aspiration with positive pressure ventilation. To overcome these limitations, a separate gastric channel was incorporated into the design of the classic and further several modifications led to the development of LMA ProSeal®.SADs have a lower risk of respiratory complications like throat pain, cough and dysphagia. Initially, LMA ProSeal® was introduced in adult sizes in the year 2001, later on Paediatric sizes were introduced in 2004. A meta-analysis conducted in 2017 found LMA ProSeal® to be the best supraglottic airway device for children as it has high oropharyngeal leak pressure and a low risk of insertion. The LMA BlockBuster® is a second-generation supraglottic airway device introduced in early 2012. Successful studies with LMA BlockBuster® have been carried out for controlled ventilation in adults with high oropharyngeal leak pressure (OLP). However, there is limited literature regarding the use of LMA BlockBuster® in paediatric patients. In this study, we aim to compare the performance characteristics of LMA ProSeal® and LMA BlockBuster® in children undergoing surgical procedures under general Anaesthesia. Seventy children aged between 1 year to 12 years with normal airways will be randomized into two groups using a computer-generated random number table. Inclusion Criteria: ASA I and II patients, Both male and female patients between 1-12 years, Elective procedures under General Anaesthesia. Exclusion Criteria: Parents/Patient attendant not giving consent, Weight less than 5 kg, Patients with BMI > 30 kg/m2, History of recent upper respiratory tract infection, Inadequate fasting, Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.), Patients with abnormal/distorted anatomy of the upper airway, Head, neck and oral surgery, Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.), Emergency surgeries. After taking the patient to the operation theatre and administration of general anaesthesia, an appropriate size supraglottic airway will be inserted according to the age groups. Success and ease of supraglottic airway insertion, time of supraglottic airway insertion, oropharyngeal leak pressure, leak fraction, success and ease of gastric tube insertion, time of gastric tube insertion, and adverse effects were noted. The glottic view will be graded by fibreoptic scoring. Following surgery, residual neuromuscular paralysis will be reversed with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg BW. The device will be removed when the patient will be awake and responsive. The patient will be inspected for any complications related to LMA insertion like -injury to lips, tongue, teeth and oropharyngeal tissues. On removal of the device presence of blood stain, will be noted. Cough, sore throat, change of voice, and dysphagia will be recorded (at 1h, 6h, 12h, and 24h). |