CTRI Number |
CTRI/2017/10/010157 [Registered on: 23/10/2017] Trial Registered Retrospectively |
Last Modified On: |
18/12/2017 |
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 Heart rate and blood pressure responses to laryngoscopy and tracheal intubation using two laryngoscopes in cervical spine injury patients |
Scientific Title of Study
|
Comparison of hemodynamic responses to laryngoscopy and tracheal intubation using Macintosh and AirtraQ® laryngoscope in patients with simulated cervical spine injury |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nithin Mathew |
Designation |
Junior Resident |
Affiliation |
Kasturba Medical College , Manipal |
Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
nibithan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Yogesh K Gaude |
Designation |
Assistant Professor |
Affiliation |
Kasturba Medical College , Manipal |
Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
yogeshgaude@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Yogesh K Gaude |
Designation |
Assistant Professor |
Affiliation |
Kasturba Medical College , Manipal |
Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
yogeshgaude@gmail.com |
|
Source of Monetary or Material Support
|
PG thesis fund, Manipal University, Manipal |
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [NA] |
|
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 Nithin Mathew |
Kasturba Hospital |
Department of Anaesthesiology. OT Complex,Manipal University, Madhavnagr, Manipal Udupi KARNATAKA |
7259616541
nibithan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
American Society of Anaesthesiology physical status 1 and 2, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
AirtraQ® laryngoscope |
Group A: AirtraQ® laryngoscope size 3 (Regular) for 7.0 – 8.5ID ET tubes and size2 (Small) for 6.0 – 7.5 ID ET tubes |
Comparator Agent |
Macintosh laryngoscope |
Group M: Macintosh laryngoscope blade size 3 for females and size 4 for males for laryngoscopy |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients in 18 to 60 year age group, weighing 40 to 70kg, belonging to ASA PS 1 or 2, scheduled for elective surgery under general anaesthesia requiring tracheal intubation, systolic blood pressure <140mm Hg and diastolic blood pressure <90mmHg on preoperative assessment. |
|
ExclusionCriteria |
Details |
1.Hypertension/Hypotension
2.Ischaemic heart disease
3.Anticipated difficult airway
4.Pregnancy or lactation
5.Signs and symptoms of raised intracranial pressure
6.Head injury
7.Cervical spine disease
8. BMI>30kg/m2
9. 2nd or 3rd degree heart block
10.Risk of gastric aspiration
11.Reactive airway disease
12.Patients on drugs affecting blood pressure/HR
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The outcome variables of heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) mean arterial pressure (MAP) will be recorded |
Pre-induction Baseline value
1 minute before intubation
At intubation and 4. Every minute for five minutes after intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of Intubation
Intubation Attempt
Ease of intubation
Glottic View |
At the time if Intubation |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/10/2013 |
Date of Study Completion (India) |
22/12/2014 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
No Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Laryngoscopy
and tracheal intubation are associated with varied levels of sympathetic
stimulation. The accompanying increase in heart rate and blood pressure can
have deleterious effects. Patients with cardio vascular compromise, elderly,
neurological insult requires measures to curb or avoid these changes. Various
pharmacological agents have been used to blunt the fluctuations in hemodynamic
parameters. The choice of airway equipment can also play a role in the severity
of sympathetic stimulation to laryngoscopy and intubation. There is mechanical
stretch and stimulation of structures of the airway during laryngoscopy. The
magnitude of cardio vascular response is related to the force and duration of
laryngoscopy. The alterations in hemodynamic parameters have deleterious
effects on patient physiology and is best avoided or attenuated.Most often
patients after trauma have associated head injury. This subgroup requires
maintenance of hemodynamic and intracranial pressure. However not many studies
have compared the difference with respect to hemodynamic changes among various
airway equipments. [1]The AirtraQ® is a novel
intubation device that has been developed to facilitate tracheal intubation in
patients with normal or difficult airways. The blade of the AirtraQ® consists of two side by
side channels. One channel acts as a conduit through which a tracheal tube
(ETT) can be passed, whilst the other channel contains a series of lenses,
prisms and mirrors that transfers the image from the illuminated tip to a
proximal viewfinder, giving a high quality wide-angle view of the glottis and
surrounding structures, and the tip of the tracheal tube.[2]
Patients with suspected cervical injury requiring
intubation depend on such airway device as alignment between oral, pharyngeal
and laryngeal axes are not required. Macintosh laryngoscope blade is still the
most widely used airway device also being used in patients needing manual in
line stabilization. Thus we wish to compare these two devices for use in
patients with simulated cervical spine injury with respect to the hemodynamic
fluctuations produced in each of them. |