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CTRI Number  CTRI/2022/10/046878 [Registered on: 28/10/2022] Trial Registered Prospectively
Last Modified On: 26/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two airway securing devices in patients undergoing Cerebrospinal Fluid Diversion Surgery. 
Scientific Title of Study   Comparison of Proseal Laryngeal Mask Airway and Endotracheal Intubation in Patients undergoing Ventriculo-Peritoneal Shunt Surgery: A Prospective Randomized Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anu Sharma 
Designation  Junior Resident  
Affiliation  PGIMER Chandigarh 
Address  Department of Anesthesia And Intensive Care PGIMER CHANDIGARH
Department of Anaesthesia And Intensive Care PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India 
Phone  7018715720  
Fax    
Email  sharma13anuu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amiya Kumar Barik 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Anaesthesiology 4th floor, Nehru Hospital PGIMER Chandigarh
Department of Anaesthesiology 4th floor, Nehru Hospital PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  08052919523  
Fax    
Email  amiyabarik.scb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amiya Kumar Barik 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Anaesthesiology 4th floor, Nehru Hospital PGIMER Chandigarh
Department of Anaesthesiology 4th floor, Nehru Hospital PGIMER Chandigarh

CHANDIGARH
160012
India 
Phone  08052919523  
Fax    
Email  amiyabarik.scb@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research Chandigarh 
Address  Department of Anaesthesia and Intensive Care 4th Floor, Nehru Hospital PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Amiya Kumar Barik  Post Graduate Institute of Medical Education and Research (PGIMER)  Department of Anaesthesiology 4th floor, Nehru Hospital PGIMER Chandigarh
Chandigarh
CHANDIGARH 
08052919523

amiyabarik.scb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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 
Comparator Agent  Endotracheal Intubation  Endotracheal Intubation will be used in patients of group E to secure the airway and administer anaesthesia till the completion of surgery.  
Intervention  Proseal Laryngeal Mask Airway  Proseal Laryngeal Mask Airway will be used in patients of group P to secure the airway and administer anaesthesia till the completion of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 to 65 years, either gender
2. ASA I and II
3. Scheduled for VP shunt surgery under general anaesthesia will be included in the study.
 
 
ExclusionCriteria 
Details  1. Patients refusal to participate in the study.
2. Features of acute raised intracranial pressure (bradycardia with hypertension, deranged neurological status, and active nausea and vomiting)
3. Patient with an anticipated difficult airway
4. ASA Physical Status III or IV
5. Body mass index >30 kgm−2
6. Upper respiratory tract infection
7. Increased risk of aspiration (unknown nil per os status, gastroesophageal reflux disorder, hiatus hernia, pregnancy, and diabetic patients)
8. Cervical spine fracture or instability 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the change in ONSD  5 minutes from baseline after securing the airway between both groups 
 
Secondary Outcome  
Outcome  TimePoints 
• Comparison of the hemodynamic parameters (Heart rate, Mean arterial pressure, oxygen saturation)
• Ventilation parameters like tidal volume (VT), respiratory rate (RR), and peak airway pressure.
• Time taken and the number of attempts to secure the airway.
• The surgeon’s and anesthesiologists satisfaction with techniques
• Intraoperative and postoperative complications (within 24 hours).
 
Intraoperative and up to 24 hours postoperative period 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/11/2022 
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    
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [amiyabarik.scb@gmail.com].

  6. For how long will this data be available start date provided 30-09-2023 and end date provided 30-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

After clearance from the institutional ethical committee (IEC), registering in CTRI, and obtaining written informed consent, 50 patients will be randomized into two study groups based on a computer-generated random numberThe group allocation will be concealed by keeping the numbers in sealed opaque envelopes that will be opened just prior to shifting the patient to the operation room (OR).

The patient will be shifted into the OR and standard American Society of Anesthesiologists (ASA) monitoring like electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SPO2), and temperature will be initiated. An intravenous (IV) line will be secured and 0.9% normal saline will be infused. General anaesthesia induction will be done with an IV injection of fentanyl 2mcg/ kg and injectionpropofoL 1-2.5 mg/kg in titration till loss of verbal response. After establishing bag and mask ventilation, IVinjectionvecuronium 0.1 mg/kg will be used for muscle relaxation under the guidance of neuromuscular transmission (NMT) monitoring. Preoxygenation will be carried out for four minutes. Following the airway will be secured with either PLMA or ETI as per group allocation.

Group P: PLMA (size 3 for 30–50 kg, size 4 for 50–70 kg, and size 5 for >70 kg patients) will be used to secure the airway.

Group E: ETT (size 8.0/8.5 mm for males and size 7.0/7.5 mm for females) of appropriate size will be used to secure the airway.

Proper placement of the PLMA and ETT will be confirmed by capnography, bilateral symmetrical chest rises, and air entry on chest auscultation. No audible leaking sound, good thoracic undulation, stable pulse oxygen saturation (>95%), and capnography will be considered successful ventilation. Air leaks will be verified by auscultation at the different head positions (neutral, anterior flexion, and left and right rotation) to determine whether ventilation of PLMA is successful. If PLMA fails (more than 3 attempts) to achieve successful ventilation, then the airway will be secured with ETI. Patients in both groups will be ventilated using volume control mode and tidal volume (VT) and respiratory rate (RR) will be adjusted to maintain end-tidal carbon dioxide between 30-35 mm Hg. Maintenance of anaesthesia will be done with 50:50% oxygen:nitrous oxide with sevoflurane, intermittent vecuronium [as per train of four (TOF) count], and fentanyl as per patient requirement. In both groups, ONSDs will be measured in both eyes using an ultrasonography device in the supine position. A Tegaderm will be used to cover the closed eye so that the water-soluble gel doesn’t enter the eye. A 7.5 MHz linear ultrasound probe will be gently placed in a transverse plane over the gel. The ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The ONSD measurement values will be determined for each eye by calculating the mean value of the 3 measurements. It will be measured before intubation (T0), immediately after intubation (T1), after 5 minutes (T2), and after 10 minutes (T3). The patient will be handed over to the surgeon to carry out the surgery. Following completion of the surgery, with the onset of spontaneous respiration and a TOF count of 4, the patient will be reversed with IVinjectionglycopyrrolate 10 mcg/kg and injection of neostigmine 50 mcg/kg. PLMA or ETT will be removed, once the patients become conscious and follow the command. 

 
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