| CTRI Number |
CTRI/2020/06/025642 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LARYNGOSCOPE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision Of, Changes in Body, During Intubation In Raised Blood Pressure Patient By Using Different Laryngoscope |
|
Scientific Title of Study
|
Comparative study of Hemodynamic response during Laryngoscopy and Endotracheal Intubation with MacIntosh, MacCoy and King Vision Video Laryngoscope in Controlled Hypertensive Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
URMILA PALARIA |
| Designation |
Professor |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Urmila Palaria,
Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College Rampur Road, Haldwani, Nainital,
263139
Uttarakhand
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urmila Palaria |
| Designation |
Professor |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Urmila Palaria, Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College , Rampur Road, Haldwani,
Nainital
263139
Uttarakhand
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urmila Palaria |
| Designation |
Professor |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Urmila Palaria, Department Of Anaesthesiology Critical Care Pain And Palliative Medicine, Government Medical College , Rampur Road, Haldwani,
Nainital, Uttarakhand
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Pramita
Address- SR Hostel Room No. 72 Government Medical College Haldwani Nainital Uttarakhand
263139 |
|
|
Primary Sponsor
|
| Name |
Dr Pramita |
| Address |
GMC Haldwani Campus SR Hostel Room No 72 Nainital
Uttarakhand |
| 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 Pramita |
Susheela Tiwari Hospital Government Medical College Haldwani Nainital , Uttarakhand |
Department Of Anaesthesiology Critical Care Pain And Palliative Care Medicine
Nainital
UTTARANCHAL |
9760269161
dr.pramitatamta92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE.GOVERNMENT MEDICAL COLLEGE HALDWANI NAINITAL UTTARAKHAND |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscope |
MaCintosh, MaCCoy and King Vision Video Laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I and II
2.MPS Grade I and II.
3.Patients with controlled hypertension
4.Age >20 year and <50 year
5.Body mass index <30Kg/m2
7.Surgery lasting for 1-2 hrs,
8. Elective surgery under general anaesthesia requiring endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. ASA Grade III & IV
3. MPS III & IV
4. Anticipated difficult airway
5. Laryngoscopy lasted for>30 sec and requirment of > one attempts
6. Severe Cardio-Respiratory comorbidity
7. Hepatorenal disease
8. Neuropsychiatric disease
9. Endocrinal disease
10. Emergency surguries
11. Gastro-oesophageal reflux disease (GERD/GORD)
12. Pregnant patient
13. Body mass index >30 Kg/m2) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Hemodynamic Responses Like, Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure And Mean Arterial Pressure, Spo2 ,Ecg (Arrhythmias, St –Segment Change Etc) After Endotracheal Intubation |
Baseline, 1 minutes , 2 minutes, 5 minutes, 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Assess Time For Laryngoscopy
2. To Assess Time For Intubation
3. To Assess The Postoperative Complications, if any.
|
Baseline, 1 minute, 2 minute, 5 minute , 10 minute |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
09/06/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the hemodynamic response during laryngoscope and endotracheal intubation with MacIntosh, MacCoy and king Vision Video Laryngoscope in Controlled Hypertensive Patients its a prospective , single blind study
|