| CTRI Number |
CTRI/2022/09/045372 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the most accurate method of correct positioning of endotracheal tube tip amongst the four routinely used methods. |
|
Scientific Title of Study
|
Comparison of Four Routinely Used Methods
For Positioning of Oral Endotracheal Tube Tip in the Trachea
– An Attempt to find a Simple, Easy and Accurate Method in Indian Adults
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palak Matanhelia |
| Designation |
PG Resident |
| Affiliation |
Sharda University |
| Address |
Department of Anesthesiology
2 floor.
Sharda HospitalSharda University, Knowledge Park 3, Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
|
| Fax |
|
| Email |
palak.matanhelia@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AK Sethi |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sharda University |
| Address |
Department of Anaesthesiology, School of Medical sciences and research, Sharda University, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
|
| Fax |
|
| Email |
newdraksethi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AK Sethi |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sharda University |
| Address |
Department of Anaesthesiology, School of Medical sciences and research, Sharda University, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
|
| Fax |
|
| Email |
newdraksethi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Sharda Hospital |
|
|
Primary Sponsor
|
| Name |
Sharda Hospital |
| Address |
Plot 32 34, Knowledge Park, Greater Noida |
| Type of Sponsor |
Private 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 Palak Matanhelia |
Department of Anesthesiology, School of Medical Sciences and Research |
2nd floor, B block, Sharda Hospital, Knowledge Park 3, Grater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9535065188
palak.matanhelia@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergoing elective surgeries. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I-II.
2.Normal airway with no anticipated difficulties in airway management.
3.Cormack Lehane grading 1 and 2 on laryngoscopy.
|
|
| ExclusionCriteria |
| Details |
•Patients who do not give consent to participate in the trial.
•Any cause of difficulty in bag & mask ventilation, laryngoscopy and tracheal intubation including Mallampati class III and IV and mouth opening <3 cm.
•Surgical procedure involving oral cavity, pharynx, larynx and neck.
•Significant deformities of chin, pharynx and/or larynx.
•Any space occupying lesion in upper airway.
•Neck swelling or contracture.
•History of radiotherapy in head and neck region.
•Any cervical spine disorder or lesion of base of skull.
•Distorted tracheal anatomy.
•Need for intubation with flexometallic or preformed tubes.
•H/o URTI in last 15 days.
•Risk of pulmonary aspiration of gastric contents e.g., pregnant females, full stomach, upper GIT problems like gastro esophageal reflux disease.
•BMI ≥ 35 kg/m2.
•Causes of raised intracranial pressure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To compare the percent positions of ETT tips positioned too low (3 cm above the carina) or too high (5 cm above the carina) using the four methods and to determine and compare the percentage of subjects in whom TT-tip comes in safe range of placement of 3-5 cm above the carina.
2)To know and compare the distance of proximal rim of TT cuff from the vocal cords in the four methods and to compare the percentage of subjects in whom the position of TT cuff is in the safe range of 1.5-2.5 cm below vocal cords.
|
immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine and compare the distance between upper incisors to TT tip (depth of insertion of tracheal tube).
2)To compare the upper incisors to carina distance.
3)To determine and compare the vocal cord-carina distance.
4)To determine and compare tracheal length.
5)To estimate and compare the distances after bringing the TT tip and/or cuff at the recommended and safe FOB verified positions.
6)To calculate the correlation coefficients tests of surface anatomy airway measurements with airway distances/lengths (cm)
|
immediately |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/09/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•A written informed consent for participation in the study will be obtained from each willing patient meeting the inclusion criteria after discussion of the study procedure and expected complications. •Preoperative evaluation of the patient will be done as per standard protocol. •Airway assessment will be done and Mallampati class, thyromental distance, mouth opening in the form of inter incisor gap and any restriction in flexion and extension movements of the neck will be noted. •Patients will be kept nil per os overnight before surgery, as per usual practice. •In the operation theatre, routine monitoring will be done. Patient will be made to lie supine comfortably in sniffing position.Patient will be taken under general anesthesia by routine protocol. •Cuffed ETTs available routinely in India and the Sharda hospital, and supplied by M/s Romsons Group Pvt Ltd. shall be used for the study. •Endotracheal tubes will be especially marked proximal to the proximal rim of the cuff at 0.5 cm distances and shall be used in all the groups to know the distance between the proximal rim of cuff to the vocal cords after the positioning of the ETT according to allotted method. •After the hemodynamic variables have stabilized, 100% oxygen saturation ensured and adequate depth of anaesthesia achieved, the connector of the TT will be disconnected from the anesthetic circuit and fibreoptic endoscope introduced through the tube to measure the distances from within the trachea. •All these measurements will be taken at the end of expiration and the lungs would be ventilated normally in between the measurements. •Measurements would be taken at separate depths,the carina and the tip of the tracheal tube. At each depth an adherent marker will be placed on the endoscope shaft •Fiberscope shall be withdrawn and measurements from the tip of the fiberscope to each of the markers shall be noted and distance from the tip of the tracheal tube to the carina calculated using these values. •Auscultation of chest shall be done in all patients after placement of the TT irrespective of the group to reinsure and confirm adequate and satisfactory ventilation • End tidal capnography will also be routinely done as a part of routine essential monitoring. •Anaesthesia will be maintained according to the standard guidelines practiced for all general anaesthesia cases.
|