| CTRI Number |
CTRI/2024/05/067189 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| 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
|
Comparison of the effects of two breathing tubes used during surgery under anaesthesia such as supraglottic airway device and endotracheal tube on pressure surrounding the brain in patients undergoing surgeries |
|
Scientific Title of Study
|
Comparison of the effects of supraglottic airway device and endotracheal tube on intracranial pressure in patients undergoing elective surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mugil Namashivayam Subramanian |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
8056115093 |
| Fax |
|
| Email |
mugil0003@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin Code-160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, Pin Code-160030 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Mugil Namashivayam Subramanian |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh, Pin Code-160030 Chandigarh CHANDIGARH |
8056115093
mugil0003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, GMCH, Chandigarh |
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 tube |
Intubation with endotracheal tube will be done after induction and neuromuscular blockade to secure the airway. The optic nerve sheath diameter will be measured along with hemodynamic parameters (MAP and HR) at 1 minute (T1), 5 minutes (T5), and 10 minutes (T10) after establishing the airway. Once the surgery is complete, the patient will be reversed, and the endotracheal tube will be removed. Patients will then be monitored for postoperative complications such as sore throat, dysphagia, and dysphonia in the PACU/ward at 1 hour, 6 hours, and 24 hours after surgery |
| Intervention |
Supraglottic airway device |
The supraglottic airway device (LMA Protector) will be inserted after induction and neuromuscular blockade to secure the airway. The optic nerve sheath diameter will be measured along with hemodynamic parameters (MAP and HR) at 1 minute (T1), 5 minutes (T5), and 10 minutes (T10) after establishing the airway. Once the surgery is complete, the patient will be reversed, and the supraglottic airway device will be removed. Patients will then be monitored for postoperative complications such as sore throat, dysphagia, and dysphonia in the PACU/ward at 1 hour, 6 hours, and 24 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged between 18 and 65 years of either sex
2. American Society of Anaesthesiologist (ASA) physical status I-II patients electively
scheduled for non-ophthalmic elective procedures under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. American Society of Anaesthesiologist (ASA) physical status III or more
2. Morbid obesity (BMI more than 35 kilogram per square metre)
3. History or suspicion of difficult airway (airway difficulty score more than 8)
4. More than two attempts for SGA placement
5. Past history of intra cranial or ocular surgery, diabetic neuropathy, cerebral edema,
glaucoma, any other condition with elevated ICP
6. Major maxillofacial trauma or cervical spine pathology
7. Potentially full stomach
8. Pregnant women
9. Surgery in prone position
10. Lack of consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of supraglottic airway device (LMA Protector) and endotracheal tube on
intra cranial pressure as measured through optic nerve sheath diameter (ONSD) using
transocular ultrasonography in patients scheduled to undergo elective surgeries. |
Pre induction (T0), 1 min after SGA placement/ ETT intubation (T1), 5 minutes after
SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT
intubation (T10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the first attempt success rate between supraglottic airway device (LMA
Protector) and endotracheal tube.
|
After establishment of an effective airway |
To compare the insertion time between supraglottic airway device (LMA Protector) and
endotracheal tube.
|
After establishment of an effective airway |
To compare the hemodynamic response as measured through SBP, DBP, MAP and HR
at various time intervals during surgery for both supraglottic airway device (LMA
Protector) and endotracheal tube. |
Pre induction (T0), 1 min after SGA placement/ ETT intubation (T1), 5 minutes after
SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT
intubation (T10) |
To compare the post-operative outcomes with respect to occurrence and severity of
complications like sore throat, dysphagia and dysphonia for both supraglottic airway
device (LMA Protector) and endotracheal tube. |
1 hour, 6 hours and 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The evolution of airway management highlights a shift towards supraglottic airway devices (SGAs) due to their advantages in minimizing post-operative complications and improving patient outcomes. Several studies have compared SGAs like LMA Protector to endotracheal tubes (ETT) in various surgical procedures, demonstrating benefits such as reduced hemodynamic stress response, lower incidence of post-operative symptoms, and better ventilatory parameters. Meta-analyses have also shown that second-generation SGAs provide better oropharyngeal leak pressure, with the LMA Protector exhibiting the highest efficacy. However, these devices have been sparingly studied in terms of ICP response. Rise in ICP noticed during tracheal stimulation during intubation would be well tolerated by healthy patients, but may be detrimental for certain subset of patients.Thus the current study aims to compare the effectiveness of the Laryngeal Mask Airway Protector (a second-generation supraglottic airway device) with the traditional endotracheal tube (ETT) in multiple aspects, primarily by assessing their impact on intracranial pressure as measured through Optic nerve sheath diamter (ONSD).The other comparative aspects include hemodynamic response, clinical performance of the devices and post-operative complications associated with their usage. The hypothesis is that SGAs will result in reduced alterations in ONSD, indicating potentially safer airway management.
Aim To compare the effect of supraglottic airway device (LMA Protector) and endotracheal tube on intra cranial pressure as measured through optic nerve sheath diameter (ONSD) using transocular ultrasonography in patients scheduled to undergo elective surgeries.
Objectives 1. To compare the first attempt success rate between supraglottic airway device (LMA Protector) and endotracheal tube. 2. To compare the insertion time between supraglottic airway device (LMA Protector) and endotracheal tube. 3. To compare the ONSD measurements at various time intervals during surgery between supraglottic airway device (LMA Protector) and endotracheal tube. 4. To compare the hemodynamic response as measured through SBP, DBP, MAP and HR at various time intervals during surgery for both supraglottic airway device (LMA Protector) and endotracheal tube. 5. To compare the post-operative outcomes with respect to occurrence and severity of complications like sore throat, dysphagia and dysphonia for both supraglottic airway device (LMA Protector) and endotracheal tube.
Methodology Participants will be randomly assigned to either the supraglottic airway (SGA) group or the ETT group.The study protocol outlines thorough pre anaesthesia workup including physical examinations, various tests and assessment of difficult airway. Patients will be advised on fasting and will be pre-medicated according to institutional guidelines. During anesthesia induction, standard procedures will be followed, including pre-oxygenation, induction with propofol and neuromuscular blockade. Airway management will vary based on group allocation, either with a supraglottic airway device (LMA Protector) or endotracheal intubation (ETT), with specific techniques outlined for each. Monitoring parameters, including hemodynamic parameters and optic nerve sheath diameter (ONSD), will be closely observed at designated time points pre and post-insertion of the airway devices. Analgesics and anti-emetics will be administered as necessary, and reversal agents will be used post-surgery. The study will also evaluate the post-operative complications like sore throat, dysphagia and dysphonia.
Outcome Measures Following observations will be recorded in all the patients: 1) Number of attempts taken to establish an effective airway 2) Time for achieving effective airway- defined as the time from picking up of the airway device to the correct placement of it, which would be seen with one effective end tidal capnography waveform. 3) Optic nerve sheath diameter in millimeter will be measured before induction/baseline (T0), 1 minute after SGA placement/ ETT intubation (T1), 5 minutes after SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT intubation (T10). 4) Intraoperative hemodynamic parameters [SBP, DBP, MAP and HR] will be recorded pre induction (T0), 1 min after SGA placement/ ETT intubation (T1), 5 minutes after SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT intubation (T10). 5) Any adverse outcomes during the procedure like oxygen desaturation, soft tissue or dental trauma, blood stains on device. 6) The incidence and sore throat, dysphagia and dysphonia will be checked at 1 hour, 6 hours and 24 hours after surgery. 7) Degree of postoperative sore throat using a numerical rating scale, if any. |