| CTRI Number |
CTRI/2019/02/017674 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
23/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the changes in the pressure in the eye, blood pressure and heart rate during insertion of tube in the trachea by direct laryngoscopy [ a tube meant for direct visualization of inside of the larynx] versus intubation through ILMA [ a less invasive device]. |
|
Scientific Title of Study
|
A study to compare the changes in intraocular
pressure and haemodynamic parameters
during endotracheal intubation by direct
laryngoscopy versus intubation through ILMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
PGIMS UHS |
| Address |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
PGIMS UHS |
| Address |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9729978861 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Arora |
| Designation |
Junior resident |
| Affiliation |
PGIMS UHS |
| Address |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
rupali.arora005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak |
| 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 Kirti Kshetrapal |
PGIMS UHS Rohtak |
Department of Anaesthesiology and Critical Care PGIMS UHS Rohtak
Rohtak
HARYANA |
9215650615
kamalkirti47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt B D Sharma Institute of medical sciences UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 patients. |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation using laryngoscope |
Recording the changes in intraocular pressure and haemodynamic parameters during and after intubation using laryngoscope. |
| Comparator Agent |
Endotracheal intubation via ILMA |
Recording the changes in intraocular pressure and haemodynamic parameters during and after intubation via ILMA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status (I and II) and Mallampati grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
refusal to participate in the study
chronic or acute lung disease.
anticipated difficult intubation
BMI > 35 kgm-2
pregnancy
increased risk of aspiration (eg. GERD / full stomach)
• glaucoma or ocular hypertension
• external ocular infections
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rise in IOP is lesser in the ILMA group. Hence intubation via ILMA should preferred in patients of glaucoma or open eye injury patients. |
Baseline (Premedication room).
After endotracheal intubation (Group DL – by direct laryngoscopy, Group IL- through ILMA, before removal of the device).
2 min. and 5 min. after intubation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use of ILMA for intubation is also associated with lesser rise in blood pressure and heart rate compared to that in intubation via laryngoscopy. Hence, it should be preferred in patients at risk of myocardial ischemia or stroke. |
Baseline
Before induction
Before device or endotracheal tube insertion.
Just after endotracheal intubation.
2 min, 5 min., 7min, 10 min, 15 min and 30 min after endotracheal tube insertion.
|
|
|
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)
|
17/02/2019 |
| 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)
Modification(s)
|
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
|
Endotracheal intubation by direct laryngoscopy
is the commonest method of securing a definite airway in most of the surgeries
that are performed under general anaesthesia. However, it is associated with
stress responses due to increased sympathetic discharge that causes rise in
intraocular pressure and tachycardia along with increase in blood pressure. Temporary rise in heart rate and blood pressure may not be a problem in a healthy
individual but it may have deleterious effects in patients with hypertension, myocardial
insufficiency or cerebrovascular disease. Acute rise in intraocular pressure can
be hazardous in patients with glaucoma and penetrating eye injury where even
small rise in intraocular pressure may convert critical disc perfusion into
disc ischemia and extrusion of eye ball contents resulting in blindness. To avoid such complications, many attempts have been made to decrease the acute
cardiovascular and ocular responses following laryngoscopy and endotracheal
intubation. Use of laryngeal mask airway is one such alternative to
endotracheal intubation due to its minimal effects on haemodynamics and
intraocular pressure. |