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CTRI Number  CTRI/2014/10/005136 [Registered on: 22/10/2014] Trial Registered Retrospectively
Last Modified On: 08/10/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two different technique of Proseal LMA placement(tube in air passage). 
Scientific Title of Study   Prospective study to compare two different technique of Proseal LMA placement. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177050  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaykumar Khandale 
Designation  PG Student 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  09869743976  
Fax    
Email  drvijaykhandale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177050  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre 
 
Primary Sponsor  
Name  Dr Sheila Nainan Myatra 
Address  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India  
Type of Sponsor  Other [Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila N Myatra  Tata Memorial Centre  Department of Anaesthesia, Critical Care, Pain, 2nd floor OT Complex, Main Building, Tata Memorial Centre, Dr. E. Borges Road, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 
02224177050

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1) Adult patients (18-80 years) in whom LMA insertion is planned 2) Belonging to ASA I and II posted for elective surgeries 3) Modified Mallampati Score I/II ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLMA insertion with a novel technique using stylet (ST) )  Patients will be randomly allocated to either standard insertion technique using the introducer tool (IT) or the novel technique using the stylet (ST) instead of the introducer to preshape the LMA (determined by opening an opaque sealed envelope) 
Intervention  PLMA insertion with conventional technique using introducer (IT)  Patients will be randomly allocated to either standard insertion technique using the introducer tool (IT) or the novel technique using the stylet (ST) instead of the introducer to preshape the LMA (determined by opening an opaque sealed envelope)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion Criteria: -
1) Adult patients (18-80 years) in whom LMA insertion is planned
2) Belonging to ASA I and II posted for elective surgeries
3) Modified Mallampati Score I/II
 
 
ExclusionCriteria 
Details  Patients with
1) Any Contraindication for PLMA placement
2) Emergency Surgery
3) Anticipated difficult airway 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
First intubation success rate  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
No of Intubation attempts
Time taken for placement
Complication rates
 
6 Months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/09/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a prospective randomized control trial. Adult consenting ASA 1 and 11 patients (Age 18-80 years) who are planned to receive an LMA for airway management for their surgery under general anaesthesia will be included.

A standard anesthesia protocol for LMA insertion practiced at TMC will be followed and routine monitoring applied (continuous ECG,ETC02,non invasive blood pressure and oxygen saturation monitoring)  Patients will administered oxygen for 3 min. Induction of anesthesia was with Fentanyl 2–4 mg/kg and Propofol 2.5–4.0 mg/kg given over 30 s.

Once the jaw is relaxed the mouth will be opened and the PLMA inserted by an anaesthetist well trained in LMA insertion (more than 2 years of anaesthesia training and > 50 LMA insertions) Patients will be randomly allocated to either standard insertion technique using the metal introducer tool (IT) or the novel technique using the plastic stylet (ST) instead of the introducer to preshape the LMA  (determined by opening an opaque sealed envelope)

The IT technique involves attaching the IT,using a single-handed rotational tech-nique to press the PLMA into, and advance it around, the palatopharyngeal curve, and then removing the IT. The ST technique involves introducing the stylet through the drain tube upto the tip of the PLMA and then preshaping the PLMA using the stylet. Insertion technique is similar to that of the IT technique, After placement the stylet will be removed.

The size of proseal LMA used will be as recommended the manufacturer

Weight

PLMA size

30-50

3

50-70

4

70-100

5

 

Both techniques will be performed with the cuff fully deflated and using a midline approach. Once the PLMA was inserted into the pharynx, the cuff was inflated with air using the maximum recommended inflation volume. Time taken for the PLMA insertion will be noted. (Time for opening the mouth to completion of LMA insertion (removal of stylet/introducer tool) When insertion will is successful, intracuff pressure will set at 60 cm H 2O using cuff pressure monitor and PLMA will be fixed with tube tape. Patients lungs will be ventilated at an inspired tidal volume of 8- 10 mL/kg, a respiratory rate of 12/min and an inspiratory:expiratory ratio of 1:2.

The presence/absence of oropharyngeal air leaks  (detected by listening over the mouth ), gastric air leaks (detected by listening with a stethoscope over the epigastrium ), drain tube air leaks (detected by placing lubricant over the proximal end of the drain tube), or an end-tidal CO2 >45 mm Hg will noted. A well-lubricated 60-cm long, 12-Fr gastric tube was inserted through the drain if there is no air leak up the drain tube. Correct gastric tube placement is assessed by suction of fluid or detection of injected air by epigastric stethoscopy.

Three attempts were allowed before insertion was considered a failure. Failed insertion was defined by any of the following criteria: 1) failed passage into the pharynx; 2) malposition (air leaks or failed gastric tube insertion if pharyngeal placement successful) and 3)ineffective ventilation (maximum expired tidal volume < 8 mL/kg or end-tidal CO2 > 45 mm Hg if correctly positioned).

Once PLMA placement is successful as judged by clinical parameter ,a fiberscope will be quickly inserted through the PLMA (through the ventilating tube) and the placement of the PLMA will be graded (less than 30 seconds) as per Brimacombe classification(Grade I-IV) .This will tell us the exact position of the LMA.

The airway position was scored from the mask aperture bars by using the system proposed by Brimacombe and Berry.

4 = only vocal cords visible;

3 = vocal cords plus posterior epiglottis visible;

2 = vocal cords plus anterior epiglottis visible;

1 = vocal cords not fiberoptically visible;

0 = failure to insert or to function.

Cardiorespiratory data were collected (every minute) for 5 minutes before and after PLMA insertion. Any episodes of bradycardia (HR <40/min), tachycardia >100/min, or systolic hypotension (SBP < 80 mm Hg,hypertension SBP > 160 mm Hg) will be documented,  any episodes of hypoxia (Spo2< 90%) or other adverse events will be noted. Any visible trauma during insertion will be noted. Visible blood staining on the stylet , IT, or PLMA was noted at removal.

Data about failed passage into the pharynx, insertion time, and the etiology of failure were collected by an unblinded observer. Data about malposition, effective ventilation, hypoxic episodes, and blood staining will be collected by an observer blinded to the insertion technique. 

 
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