CTRI Number |
CTRI/2018/06/014473 [Registered on: 08/06/2018] Trial Registered Prospectively |
Last Modified On: |
07/06/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative efficacy and safety of two supraglottic airway devices during general anaesthesia in children |
Scientific Title of Study
|
Comparative efficacy and safety of I-gel supraglottic airway and self pressurizing Air-Q intubating laryngeal airway during general anaesthesia in infants: A prospective randomised study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ravinder Kumar Pandey |
Designation |
Professor |
Affiliation |
All India Institute Of Medical Sciences New Delhi |
Address |
Room No 5016 teaching block
Department of Anaesthesiology AIIMS Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS New Delhi DELHI 110029 India |
Phone |
9868397817 |
Fax |
|
Email |
ravindrapandey1972@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Neha Pangasa |
Designation |
Senior Resident |
Affiliation |
All India Institute Of Mediical Sciences New Delhi |
Address |
Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS New Delhi DELHI 110029 India |
Phone |
9810383313 |
Fax |
|
Email |
nehapangasa@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Neha Pangasa |
Designation |
Senior Resident |
Affiliation |
All India Institute Of Mediical Sciences New Delhi |
Address |
Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS New Delhi DELHI 110091 India |
Phone |
9810383313 |
Fax |
|
Email |
nehapangasa@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology Pain Medicine and Critical care
AIIMS New Dehi |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology Pain medicine and Critical care |
Address |
All India Institute Of Medical Sciences New Delhi |
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 Ravinder Kumar Pandey |
All India Institute Of Medical Sciences |
Main Operation theater , 5th floor. Rajendra Prasad Centre for ophthalmic sciences New Delhi DELHI |
9868397817
ravindrapandey1972@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethical committee of All India Institute Of Medical Sciences New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA I and II children below 1 year of age posted for ophthalmic surgery of 20 min-2 hr duration, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Air-Qsp |
The air-Qsp, which is a new self-pressurizing masked laryngeal airway has a unique cuff design. The mask cuff of Air-Qsp inflates appropriately upon inhalation with positive pressure ventilation, and decompresses upon exhalation to the level of PEEP. Moreover, the cuff is not overinflated by high positive pressure or nitrous oxide, because it is not a closed cavity. Six colour-coded single patient use sizes Air-Qsp are available (1.0, 1.5, 2.0, 2.5, 3.5, 4.5).Acceptable clinical performance has been demonstrated with the Air-Qsp for a variety of procedures in infants and children with spontaneous and positive pressure ventilation. |
Comparator Agent |
I-gel |
The i-gel airway (Intersurgical Ltd, Wokingham,Berkshire, UK) is a novel supraglottic device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel-like feel. The mask of the i-gel is designed anatomically to fit the perilaryngeal and hypopharyngeal structures without the use of an inflatable cuff.
Paediatric i-gel is available in different sizes (1, 1.5, 2, and 2.5) according to the weight of the children.In children the i-gel is very easy to insert and no learning curve is needed before a high success insertion rate is obtained. A positive pressure is easily achieved without gastric inflation or pharyngeal leak. Moreover, the drainage tube makes it possible to confirm the correct position of the device and allows gastric drainage. Therefore, the i-gel appears to be safe for paediatric airway management. |
|
Inclusion Criteria
|
Age From |
1.00 Day(s) |
Age To |
1.00 Year(s) |
Gender |
Both |
Details |
Infants below 1yr. of age
Posted for Only elective ophthalmic surgery
ASA I & II patients
Duration of surgery (20 mins-2 hrs) |
|
ExclusionCriteria |
Details |
All patients above 1 year of age
Not willing to consent (Consent taken from parents)
Infants with any-airway anomalies, active URTI, known difficult airway, lung disease requiring high PEEP
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Oropharyngeal Leak Pressure (in cm H2O) |
Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. First insertion success rate
2. Time to insert (in seconds)
3. No. of attempts for successful insertion
4. Fibreoptic bronchoscopic view of glottis through the supraglottic airway device
5. Post op. Complications (repeated episodes of cough, laryngospasm, desaturation)
|
Time to Insert- Time between picking up the device and chest rise with PPV
Fibre-optic bronchoscopic (FOB) view-breathing system will be briefly disconnected after insertion and confirmation of device
and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view.
Post-operative Complications- Blood stain on device (oropharyngeal trauma), repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted after removal of device at the end of surgery
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
15/06/2018 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
We will be comparing the efficacy and safety of i-gel supraglottic airway and self pressurizing air-q intubating laryngeal airway during general anaesthesia in infants. The study will include 100 infants, ASA I and II, posted for elective ophthalmic surgery of 20 min-2 hrs duration. All patients above 1 year of age, not willing to consent and infants with any airway anomalies, active URTI, known difficult airway or lung disease requiring high PEEP will be excluded from the study. Randomization will be done by computer generated random number tables and group allocation will be done by opening sealed opaque envelopes. The primary objective of our study is to compare the oropharyngeal leak pressure of i-gel and air-Qsp and the secondary objectives are to compare the two devices in terms of- number of attempts to successfully insert the device, time to insert, fibre-optic view of glottis through the device and post-operative complications like cough, laryngospasm and desaturation. All ASA I-II infants will receive standardised general anaesthesia. A pre-anaesthetic check-up will be done for all patients one day prior to the surgery. On being shifted to operation theatre, the standard monitors will be attached. Anaesthesia will be induced by using sevoflurane in oxygen by increasing inspired concentration of sevoflurane (from 2-8%) till the loss of eyelash reflex. 22 or 24G IV cannula will be secured. Then intravenous fentanyl 1μg/kg and atracurium 0.25 mg/kg will be given. After 3 minutes of intermittent positive pressure ventilation, appropriate size (depending on body weight) of supraglottic device (according to the group allocated) lubricated with jelly will be inserted and circuit attached. Chest rise and ventilation will be confirmed. Satisfactory SGA placement will be confirmed by the appearance of square wave capnogram and absence of leak around SGA. A maximum of 3 attempts will be allowed. If more than 3 attempts are required, then it will be considered as failure and an alternative device or endotracheal intubation will be done Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery. After initial measurement of oropharyngeal leak pressure, the breathing system will be briefly disconnected and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view. Anaesthesia will be maintained with isoflurane 1- 2% (MAC 0.8 – 1.0) in O2: Air mixture with Fio2 of 0.5. Pressure controlled ventilation to be used to maintain normocarbia (35 – 40 cm of H2O).. Intra-operative analgesia will be maintained by IV Paracetamol (7.5 mg/kg). At the end of surgery, isoflurane will be turned off & 100% O2 will be administered. Muscle relaxation will be reversed by intravenous neostigmine (50μg/kg) & glycopyrrolate (10μg/kg). Adequate tidal volume & regular respiration will be maintained. Oropharyngeal suctioning will be done & device will be removed. Presence of any blood stain or any tongue, lip or dental trauma will be noted. Any post-operative complication such as repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted till 1 hr post operatively. |