| CTRI Number |
CTRI/2023/05/053300 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two positions for intubation with videolaryngoscope in obese patients |
|
Scientific Title of Study
|
Comparison of ramped versus sniffing position for orotracheal intubation using videolaryngoscope in obese patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIPIN M |
| Designation |
POST GRADUATE RESIDENT, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES |
| Address |
room No 631 B
Department of Anaesthesiology
UCMS and GTBH
Delhi
East
DELHI
110095
India |
| Phone |
8903674165 |
| Fax |
|
| Email |
muralivipin18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Room No 631 B
Department of Anaesthesiology
UCMS and GTBH
East
DELHI
110095
India |
| Phone |
9911317334 |
| Fax |
|
| Email |
rashmichabra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Room No 631 B
Department of Anaesthesiology
UCMS and GTBH
East
DELHI
110095
India |
| Phone |
9911317334 |
| Fax |
|
| Email |
rashmichabra@yahoo.com |
|
|
Source of Monetary or Material Support
|
| UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL
Dilshad Garden Delhi |
|
|
Primary Sponsor
|
| Name |
University College of Medical Siences |
| Address |
Dilshad Garden
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 RASHMI SALHOTRA |
University College of Medical Sciences |
Department of Anaesthesiology
Room No 631 B
UCMS and GTBH
Dilshad Garden, DELHI
East
DELHI |
9911317334
rashmichabra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-HUMAN RESEARCH, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ramped position for intubation |
Ramped position which will be given by giving a head-elevated laryngoscopy
position (HELP) by lifting the head end of the operating table to align the sternal notch with
the external auditory meatus objectively determined using the Spirit Level-Scale assembly. |
| Comparator Agent |
Sniffing position for intubation |
Sniffing position: Head will be placed on a non-compressible pillow with a height of
8-10 cm |
| Intervention |
Videolaryngoscopy |
After induction of anaesthesia intubation will be performed once within 60 second using a Tuoren videolaryngocope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
A total of 30 (15 in each group) consenting patients >18 years of age belonging to either sex,
ASA physical status I-III having BMI>30 kg/m2
with Mallampatti class I-IV airways scheduled
for elective surgical procedures requiring general anaesthesia with tracheal intubation will be
enrolled |
|
| ExclusionCriteria |
| Details |
Cases where awake intubation is planned (without induction of anaesthesia and muscle
relaxation).
Patients requiring rapid sequence intubation (full stomach, pregnant, emergency,
gastroesophageal reflux disease, emergency laparotomy).
Patients with bleeding diathesis.
Patients with neck mass, neck irradiation, restricted neck mobility, cervical spine
injury/pathology, oral cavity growths.
Patients with h/o upper respiratory tract infection in the last 1 month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required for successful intubation |
Once after intubation is done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate in the first intubation attempt
Difficulty in mask ventilation
Laryngoscopy time
Tube insertion time
Intubation difficulty score |
Once after intubation is complete |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2023 |
| Date of Study Completion (India) |
30/11/2024 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title: Comparison of Ramped versus Sniffing position for orotracheal intubation using
videolaryngoscope in obese patients.
Rationale and Aims: Obesity is associated with an anticipated difficult airway. Patient
positioning is a very important and often neglected aspect of airway management in obese with
the ramped or head elevated laryngoscopy position being the most suitable for direct
laryngoscopy. However, the best position for videolaryngoscopy in obese patients is yet to be
researched. This study is aimed to compare ramped position versus sniffing position for
orotracheal intubation using videolaryngoscope in obese patients in terms of time required for
successful intubation, success rate in the first intubation attempt, difficulty in mask ventilation,
laryngoscopy time, tube insertion time, intubation difficulty score, complications (oesophageal
intubations, intubation failures, incidence of desaturation, trauma, sore throat and hoarseness).
Methods: This prospective randomised study will be conducted between May 2023 and
November 2024 after obtaining ethical approval and written informed consent from all patients.
A total of 30 (15 in each group) consenting patients >18 years of age belonging to either sex,
ASA physical status I-III having BMI>30 kg/m2
with Mallampatti class I-IV airways scheduled
for elective surgical procedures will be enrolled. Patients requiring awake intubation, rapid
sequence intubation, having bleeding diathesis, neck mass, neck irradiation, restricted neck
mobility, cervical spine injury/pathology, oral cavity growths or h/o upper respiratory tract
infection in the last 1 month will be excluded. Patients will be randomly allocated to either
group R (ramped position) or group S (sniffing position) based on a computer-generated
random number table. General anaesthesia will be induced as per standard protocol. After
complete muscle relaxation, Tuoren video-laryngoscope will used for intubation.
Sample size estimation and Statistical Analysis: Considering the total intubation time as 22.5
± 6.2 s in the ramped position and 40.9 ± 9.0 s in sniffing position as per a previous study (7),
to estimate a clinically important difference of 10 s in mean intubation time at α = 5% and
power = 90%, a sample of 15 patients is required in each group. So, we propose to include total
30 cases, 15 in each group. Data will be entered on a spreadsheet, cleaned and analysed using
SPSS version 20.0. One time measured quantitative parameters between the groups will be
compared by unpaired t-test or Mann Whitney U-test depending upon nature of data.
Qualitative parameters will be compared by χ2
testor Fisher’s exact test. A P-value<0.05 will
be taken as significant. |