| CTRI Number |
CTRI/2021/04/033273 [Registered on: 30/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| 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 supine and 25 degree head up position for intubation using two different video-laryngoscopes |
|
Scientific Title of Study
|
Comparison of intubating conditions in supine(sniffing) and 25 degree back up position using channelled and non channelled video-laryngoscopes- A prospective randomized controlled 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 Riddhi Sompura |
| Designation |
2nd yr resident |
| Affiliation |
Government Medical College Baroda |
| Address |
Department of Anaesthesiology,
Government Medical College Baroda
Department of Anaesthesiology,
Government Medical College Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
8733057878 |
| Fax |
|
| Email |
riddhi1625@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devyani Desai |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Department of Anaesthesiology,
Government Medical College Baroda
Department of Anaesthesiology,
Government Medical College Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9909983168 |
| Fax |
|
| Email |
devyani.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devyani Desai |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Department of Anaesthesiology,
Government Medical College Baroda
Department of Anaesthesiology,
Government Medical College Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9909983168 |
| Fax |
|
| Email |
devyani.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Baroda |
|
|
Primary Sponsor
|
| Name |
Government Medical College Baroda |
| Address |
Department of Anaesthesiology
Government Medical College Baroda |
| 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 Riddhi Sompura |
Government Medical College, SSG Hospital, Baroda |
Department of Anaesthesiology
government Medical College,
SSG Hospital, Baroda
Vadodara
GUJARAT |
8733057878
riddhi1625@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research(IECBHR) Medical College and SSG Hospital Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
25 degree back up position |
Intubation in 25 degree back up position using McGrath and King Vision video-laryngoscopes |
| Comparator Agent |
Supine(sniffing) position |
Intubation in supine(sniffing) position using McGrath and King Vision video-laryngoscopes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA â… and â…¡
Mouth opening ≥ 3cm
Mallampati grading 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient not willing for participation
Patients with difficult airway
Morbid obesity(BMI >35)
Oral cavity surgeries
Pre-existing tracheal or laryngeal pathology
Patients requiring rapid sequence intubation
Pregnancy |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Difficult Intubation Scale(mIDS) |
Modified Difficult Intubation Scale will be assessed at 0 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intubation time
2.Number of attempts of intubation
3.Vital parameters
4.Airway complications |
Baseline
1 minute after intubation
5 minutes after intubation
10 minutes after intubation
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
06/05/2021 |
| 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="8"
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 - NO
|
|
Brief Summary
|
After thorough pre-anaesthetic evaluation and 10 hours of nil by mouth, informed written consent will be taken from the patient. After taking patient inside the operation theatre, multipara monitor will be attached and baseline vital parameters including pulse rate, blood pressure and spo2 will be noted. Patient position: Patient will be given either supine(sniffing) position or 25 degree back up position according to their respective study groups. Supine position will be achieved by keeping 7 cm high non-compressible pillow under the head of the patient. 25 degree back up position will be achieved by raising the operating table to 25 degree from horizontal by flexion of the torso at the hips using the controls on the operating table so that sternal notch and external auditory meatus will be at the same level. Grouping of the patients: The study population will be randomly allocated into four groups by using sealed envelope method. Group M1: McGrath video-laryngoscope will be used in supine position. Group M2: McGrath video-laryngoscope will be used in 25 degree back up position. Group K1: King Vision video-laryngoscope will be used in supine position. Group K2: King Vision video-laryngoscope will be used in 25 degree back up position. Premedication: Inj. Glycopyrrolate 5mcg/kg IV, Inj. Tramadol 2mg/kg IV, Inj. Ondansetron 0.1mg/kg IV will be given 5 minutes before induction.
Induction: Patient will be pre-oxygenated with 100% o2 for 3 minutes. Then Inj. Lignocaine 1.5mg/kg IV f/b Inj. Propofol 2mg/kg IV till loss of eye lash reflex will be given. After check ventilation, Inj. Suxamethonium Chloride 2 mg/kg IV will be given. After disappearance of fasciculations, patient will be intubated with respective devices and first effective ventilation will be confirmed by capnography. Inj. Vecuronium bromide 0.1mg/kg loading dose will be given. Methods of endotracheal intubation: Group M1: Patient’s head will be kept in supine position and will be intubated using McGrath video-laryngoscope. Group M2: Patient will be given 25 degree back up position and will be intubated using McGrath video-laryngoscope. Group K1: Patient’s head will be kept in supine position and will be intubated using King Vision video-laryngoscope. Group K2: Patient will be intubated using King Vision video-laryngoscope in 25 degree back up position. Modified difficult intubation scale(mIDS), Intubation time, Number of attempts of intubation, vital parameters and airway complications ( desaturation, bronchospasm, oropharyngeal trauma, oesophageal intubation) if any will be noted. Maximum 2 attempts with the selected video-laryngoscope will be allowed. Failed intubation will be defined as an attempt in which patient could not be intubated even with optimization manoeuvre or more than 120 secs required to perform the procedure. Maintenance: 02 +N2O(50:50) with sevoflurane and vecuronium bromide 0.02mg/kg IV At the end of procedure, patient will be extubated after fulfilling the criteria for extubation and will be shifted to PACU.
Parameter
|
Group M1
|
Group M2
|
Group K1
|
Group K2
|
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Modified Intubation Difficulty
Scale(mIDS)
|
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PARAMETERS
|
GROUP M1
|
GROUP M2
|
GROUP K1
|
GROUP K2
|
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Intubation Time
|
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No. of Attempts of device
insertion/Intubation
|
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