| CTRI Number |
CTRI/2021/12/038728 [Registered on: 17/12/2021] Trial Registered Prospectively |
| Last Modified On: |
16/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the difference between weight based criteria and cricoid-mental distance based criteria for LMA proseal size selection in adult patients undergoing general anesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of Cricoid Mental distance based and weight based criteria for Proseal LMA size selection in Adult patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nimith Prabhakar |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, B. L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELHI 110002
India
New Delhi
DELHI
110002
India |
| Phone |
9591915787 |
| Fax |
|
| Email |
nimithp93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavita Rani Sharma |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, B. L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELHI 110002
India
New Delhi
DELHI
110002
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Rani Sharma |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, B. L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELHI 110002
India
New Delhi
DELHI
110002
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Intensive Care, B. L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELH-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELHI -110002
India |
| Type of Sponsor |
Government medical college |
|
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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 |
| Nimith prabhakar |
Lok nayak hospital |
Department of Anaesthesiology and Intensive Care, B. L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Central DELHI 110002
India
Central
DELHI |
9591915787
nimithp93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Weight based criteria for Proseal LMA size selection |
Using conventional weight based criteria for LMA proseal size selection I.e size 3 for weight 30-50 kg, size 4 for weight 50-70 kg and size 5 for weight 70-100 kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-ASA grade I, II
-Aged 18 to 60 years
-body mass index (BMI) 18 - 30kg/m2
Expected duration of surgery less than 3 hours
|
|
| ExclusionCriteria |
| Details |
-Patients with high risk of regurgitation or aspiration
-Patients with an anticipated difficult airway (including but not limited to a history of difficulty airway, mouth opening <2.5 cm, Mallampati class 4, limited neck extension or cervical spine pathology)
-Known respiratory tract pathology
-Planned surgery in lateral / prone position
-Patients requiring endotracheal intubation
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Insertion success at first attempt
|
From baseline to time of insertion
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Number of Attempts at Proseal insertion |
1st attempt, 2 nd attempt, 3rd attempt.
|
| Time to successful insertion |
the interval beginning with picking up the airway device and ending when a successful airway device placement |
| Ease of insertion |
graded from 1 to 4 (1 for no resistance, 2 for mild resistance, 3 for moderate resistance, 4 for unable to placement) by the operator who performed the insertion
|
Oropharyngeal leak pressure (OLP)
|
During monitoring of patient once the proseal LMA is in situ.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/12/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Supraglottic airway devices (SADs), especially the laryngeal mask airway (LMA), have been extensively adopted as an alternative technique to tracheal intubation or mask ventilation for airway management in short length surgery . More and more clinicians prefer SADs now than ever before. Recent studies have shown that 50% of patients under general anesthesia in the UK are ventilated with SADs . Optimal size selection is critical to the safe and effective use of the laryngeal mask airway (LMA). ideally, the optimal LMA should be easy to insert; have an oropharyngeal leak pressure sufficient for positive pressure ventilation; a pharyngeal mucosal pressure less than capillary perfusion pressure; and be positioned such that instruments pass easily into the respiratory tract. In clinical practice, however, the weight-based criterion is not always applicable, especially for patients in asthenic or stout shape as there is no linear correlation between the upper airway anatomy and body weight due to the individual anatomical variation, as previous studies have demonstrated that the first attempt success rate of LMA insertion based on weight was as low as 77% to 82% . This study will be prospectively conducted to evaluate the efficacy of cricoid-mental distance-based method versus weight-based method in optimal size selection of Proseal LMA in adults undergoing elective surgery.
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