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CTRI Number  CTRI/2023/02/049716 [Registered on: 14/02/2023] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To see effect of LMA proseal and LMA protector on heart rate and blood pressure after removing endotracheal tube and putting LMA in adult patient coming out of general anaesthesia after surgery  
Scientific Title of Study   Comparison of clinical performance of Laryngeal Mask Airway Protector versus Proseal Laryngeal Mask Airway for Bailey Manoeuvre A randomized control study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kritika Dwivedi 
Designation  Post Graduate Junior Resident  
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5, GMCH,Sector 32,Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  7351322191  
Fax    
Email  dwivedikritika2.kd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5, GMCH,Sector 32,Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5, GMCH,Sector 32,Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesia and Intensive Care 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  Department of Anaesthesia and Intensive Care,Block-D,Level-5,GMCH,Sector 32,Chandigarh  
Type of Sponsor  Government medical college 
 
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 
Kritika Dwivedi  Government Medical College and Hospital,Sector 32, Chandigarh  Department of Anaesthesia and Intensive Care,Block-D,Level-5,GMCH,Sector 32,Chandigarh
Chandigarh
CHANDIGARH 		 7351322191

dwivedikritika2.kd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,GMCH,Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laryngeal Mask Airway Proseal  To compare the hemodynamic responses and secondary parameters such as cough reflex and awakening after extubation using Baileys maneuver with Laryngeal Mask Airway Proseal.HR, BP, MAP,ECG and SPO2 values will be recorded; after SAD is inserted; after removal of ETT and continued at 1,2,3,5 and 10 minutes afterwards.Adverse effect if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD 
Intervention  Laryngeal Mask Airway Protector  To compare the hemodynamic responses and secondary parameters such as cough reflex and awakening after extubation using Baileys maneuver with Laryngeal Mask Airway Protector.HR, BP, MAP,ECG and SPO2 values will be recorded; after SAD is inserted; after removal of ETT and continued at 1,2,3,5 and 10 minutes afterwards.Adverse effect if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group of 18 to 60 years
2. ASA (American Society of Anaesthesiologists) status I and II
3. Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation. 
 
ExclusionCriteria 
Details  1. Patients with difficult airway with Airway difficulty score>8
2. Morbid obesity BMI > 35 kg/m2
3. Known airway pathology
4. Oropharyngeal surgeries
5. Surgery more than 3 hours
6. Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer
7. Previous upper gastrointestinal surgery
8. Known or anticipated difficult tracheal intubation or facemask ventilation
9. Coagulopathy or history of anticoagulant use
10. Cardio respiratory or cerebrovascular disease
11. Cervical spine injury
12. Pregnant Patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic responses during extubation using Bailey‟s maneuver with Laryngeal Mask Airway Protector or Proseal LMA  Hemodynamic response would be noted After SAD insertion,after remoal of ETT,1,2,3,5and 10 min afterward and then at SAD removal and 1,2,3,5 and 10 min afterward 
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare secondary parameters such as cough reflex awakening after extubation using Bailey‟s maneuver with Laryngeal Mask Airway Protector device or Proseal LMA.
2) To observe any adverse effects such as bleeding, trauma or sore throat, if any. 		 Adverse effect if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD). 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/02/2023 
Date of Study Completion (India) 26/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/01/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dwivedikritika2.kd@gmail.com].

  6. For how long will this data be available start date provided 02-02-2027 and end date provided 02-02-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Maintenance of a patent airway is an essential responsibility of anaesthesiologists. Extubation is equally significant as tracheal intubation in a general anaesthesia patient.Awake extubation is mostly considered as safest in anaesthetic practice but is associated with agitation which occurs as a consequence of movement of ETT against the vocal cords,this stimulus can result in tachycardia, coughing and hypertension which can be hazardous for patients especially of ENT surgery, patients with ischemic heart disease, aortic surgery.
The Bailey‟s maneuver is a technique for extubating patients in deeper plane of anaesthesia by substituting an oral endotracheal tube for a supraglottic airway device (SAD).This avoids coughing and bucking that is often undesired after certain surgical procedures.SAD has an added benefit of allowing flexible bronchoscope to assess for vocal cord mobility and laryngeal oedema
LMA Protector and LMA Proseal are SAD that can be used for performing Bailey,s Maneuver
Therefore, present study is planned to compare the clinical performance of LMA Protector™ and Proseal LMA™ for Bailey‟s maneuver during extubation.
It was decided to enroll a total of 100 subjects for the present trial for patient drop out and additional comparisons. Therefore, after the approval of protocol by the Hospital Ethics Committee, Clinical Trial Registry: India (CTRI) and obtaining informed consent from every patient, a total number of 100 patients admitted for elective surgery under general anaesthesia will be enrolled for the present study as per inclusion and exclusion criteria.

Patients will be evaluated preoperatively on the day prior to surgery,Written informed consent will be taken from all the patients enrolled for the study.Preoperative airway evaluation will be performed and routine investigation would be done for all patient.At the end of surgery,15 min prior to end of surgery, HR, BP, MAP, SPO2, ECG values will be recorded. At the end of surgery, when patient will be still under deep anaesthesia oropharyngeal suction will be done. At this moment SAD will be inserted behind the ETT and its cuff will be inflated.Fibreoptic bronchoscope will be inserted via the airway tube of LMA Protector or Proseal LMA to grade the adequate placement of the device. The grading will be noted. Then HR, BP, MAP, ECG and SPO2 values will be recorded; after SAD is inserted; after removal of ETT and continued at 1,2,3,5 and 10 minutes afterwardsAfter completion of surgery,SAD will be removed HR, BP, MAP, ECG and SPO2 will be recorded immediately after removal of SAD and 1,2,3,5 and 10 minutes afterwards. • The cough reflex and awakening after extubation will be observed • Any adverse effects such as bleeding, trauma or sore throat, if any, will be noted in postoperative room till first 24 hours post operatively (Once in post operative room and once after 24 hours of removal of SAD).
All the patient will be transferred to post operative care unit (PACU) for observation before shifting them to respective post operative wards.
All the observations will be noted in prescribed proforma



 
 
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