| CTRI Number |
CTRI/2021/04/033106 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [New technique of holding endotracheal tube] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A prospective trial to compare the efficacy of “Between the fingers Grip†with conventional “Pen holding Grip†to hold an endotracheal tube for orotracheal intubation during procedure of General Anaesthesia |
|
Scientific Title of Study
|
A prospective randomized control study to compare the efficacy of “Between the fingers Grip†with conventional “Pen holding Grip†to hold an endotracheal tube for orotracheal intubation |
| Trial Acronym |
BETI trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhat Tewari |
| Designation |
Professor |
| Affiliation |
SGPGIMS, Lucknow |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9794393344 |
| Fax |
|
| Email |
ptewari@sgpgi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhat Tewari |
| Designation |
Professor Guide of MD thesis |
| Affiliation |
Department of Anaesthesiology SGPGIMS, Lucknow |
| Address |
Type V A house no 15 SGPGI Campus SGPGIMS Raibarely road
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9794393344 |
| Fax |
|
| Email |
ptewari@sgpgi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Thakur |
| Designation |
first year junior resident (student) |
| Affiliation |
SGPGIMS, Lucknow |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9456533827 |
| Fax |
|
| Email |
thakur2soumya@gmail.com |
|
|
Source of Monetary or Material Support
|
| No financial or material support is needed |
|
|
Primary Sponsor
|
| Name |
SGPGIMS |
| Address |
Raibarely road, Lucknow 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prabhat Tewari |
Department of Anaesthesiology, SGPGIMS |
Raibarely road, Lucknow 226014
Lucknow
UTTAR PRADESH |
9794393344
ptewari@sgpgi.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 118th Institutional Ethics Committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (3) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Between the finger grip
|
Between the finger grip to hold the endotracheal tube |
| Comparator Agent |
Conventional Pen holding grip |
Endotracheal tube will be held just like a pen holding grip that is a conventional technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate
2. Cormack Lehane grade 1 / 2a / 2b / 3a
3. Intubation by experienced Anaesthesiologist
|
|
| ExclusionCriteria |
| Details |
1. CL grade 3b/4
2. Patients with anticipated difficult airway
3. Patients with pasthistory of difficult intubation
4. Patients who previously underwent tracheostomy
5. Patients having any head or neck pathology
6. Patients with restricted neck movement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rates of the modified grip with the control group (standard grip) in terms of number of attempts (upto two) and then requirement of assistance or aids to perform endotracheal intubation. |
Assessment done only once.(Ist time point)after Anaesthetic induction during laryngoscopy and endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To calculate the time required in each grip [From introduction of ETT into mouth to 1st EtCO2 graph reading]
2) To compare the hemodynamic parameters (HR and BP) in two groups [from laryngoscopy till 5 min after intubation]
|
1. Baseline
2. Laryngoscopy for CL grading
3. At the completion of intubation marked by appearance of ETCO2 trace |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2021 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation provides the most secure airway and its execution depends upon the assessment of airway and accurate laryngoscopy. This relies upon the use of different types of laryngoscopes, endotracheal tubes, and external aids. |The current literature has focused on the above mentioned in detail, still, there is a lack of evidence on the method of holding the endotracheal tube to facilitate orotracheal intubation.
Therefore, in this study, we will assess the utility of using the modified method, which is ’between the fingers’ grip to hold the endotracheal tube over the conventional ’pen holding grip’. We presume the former will provide us control for maneuvering the tip of endotracheal tube anteriorly, thus helping in endotracheal intubation.
This will be a prospective, randomized control study to compare the success rates of modified grip with the control group (standard grip) in terms of number of attempts and the requirement of assisstance to perform endotracheal intubation.
50 patients, after computer generated randomization, will be recruited in each group. Patients willing to participate, with airway assessment Cormack Lehane grade 1/ 2a/ 2b/ 3a, who are 18-60 years of age and are undergoing intubation by an experienced anaesthesiologist will be included in the study. Patients with an anticipated difficult airway, head and neck pathologies, history of difficult intubation and Cormack Lehane grade 3b and 4 will be excluded from the study.
Written and informed consent will be obtained from all the patients fulfillingthe inclusion criteria by explaining the details of the study in their language in presence of a witness.
On arrival in the operating room, anaesthetic induction will be done as per standard protocol and the patient will be positioned for endotracheal intubation. This is followed by laryngoscopy using a Macintosh blade (size 3 and 4). Laryngoscopy will be done by an anaesthesiologist with at least 3 years experience in clinical anaesthesia. The CL grading will be noted. A standard oral cuffed tracheal tube will be used according to the patient profile. Orotracheal intubation will be performed after visualizing the glottis. The conventional or modified grip of holding the endotracheal tube will be applied to the patient according to their assigned group according to the randomization table, and observation will be noted.
The assessment of each method will be done based on the following criteria, whether it was an unaided single or double attempt intubation, how much time was taken after visualization of Laryngeal inlet till 1st value of EtCO2, whether stylet of bougie was required, whether BURP was required to aid the intubation andcomparing the hemodynamic parameters during the application of each method
|