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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amiyabarik.scb@gmail.com].
- 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.
- 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 number. The 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. |