| CTRI Number |
CTRI/2024/02/062314 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of airway parameters via ultrasound for I-gel placement |
|
Scientific Title of Study
|
Evaluation of ultrasound measured airway parameters for placement of I-gel - An observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor, OT complex, PGIMS Rohtak
Rohtak HARYANA 124001 India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nitasha |
| Designation |
Postgraduate student |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor, OT complex, PGIMS Rohtak
Rohtak HARYANA 124001 India |
| Phone |
9467788897 |
| Fax |
|
| Email |
bhanunitasha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nitasha |
| Designation |
Postgraduate student |
| Affiliation |
Pt. BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor, OT complex, PGIMS Rohtak
Rohtak HARYANA 124001 India |
| Phone |
9467788897 |
| Fax |
|
| Email |
bhanunitasha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt BD Sharma PGIMS Rohtak
HARYANA
124001
India |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,PGIMS,Rohtak,Haryana,124001,INDIA |
| 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 Nitasha |
Pt BD Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care,2nd floor, modular OT complex Rohtak HARYANA |
9467788897
bhanunitasha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20-60 years of age, of either gender, belonging to American Society of Anaesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anaesthesia requiring I-gel insertion. |
|
| ExclusionCriteria |
| Details |
Patients with
Refusal to participate
Pharyngeal pathology
Gastroesophageal reflux
Low pulmonary compliance
Severe Cardio vascular disease
Facial and tongue anomalies or any other airway anomaly Temporo-mandibular joint ankylosis
Oropharyngeal pathology
History of obstructive sleep apnoea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of preoperative ultrasound measured airway parameters in guiding optimal placement of I-gel using Fiberoptic grading. |
Immediately after I-gel placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between ultrasound measured pre-operative airway parameters and
1. Ease of mask ventilation.
2. Ease of insertion of I-gel.
3. Time taken for I-gel placement. |
While placement of I-gel |
|
|
Target Sample Size
|
Total Sample Size="95" Sample Size from India="95"
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2024 |
| Date of Study Completion (India) |
01/08/2024 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is a core component of anaesthesia care. In any procedure that requires general anaesthesia, anaesthesiologists need to control the patient’s airway in order to maintain adequate ventilation and oxygenation. This can be a high-risk task and can lead to patient morbidity and mortality, due to inadequate/impossible ventilation, and/or intubation. Therefore, it is essential to optimize methods to anticipate a difficult airway and ensure the necessary means to intervene As per American Society of Anaesthesiologists (ASA) 2022 guidelines, a difficult airway includes the clinical situation in which anticipated or unanticipated difficulty or failure is seen by an experienced anaesthesiologist during facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation or invasive airway. Difficult supraglottic airway ventilation is defined as when it is not possible to provide adequate ventilation because of difficult supraglottic airway placement, supraglottic airway placement requiring multiple attempts, inadequate supraglottic airway seal, excessive gas leak, or excessive resistance to the ingress or egress of gas. Inability to anticipate difficult airway and thereby poor planning for airway management remains the primary cause of airway related complications for anaesthesiologists. Difficult airway is a potential risk in few patients which is associated with serious morbidity and mortality and poses a challenge for anaesthesiologists. There have been many techniques devised to assess difficult airways like the modified mallampati test, thyromental distance, hyomental distance, inter-incisor distance, neck movements and neck circumference. All these methods are subjective to the observer and require mandatory actions to be performed by the patients which decreases their application, especially in unconscious patients.5 Also they have less sensitivity and specificity with a limited predictive value. Despite using all the available clinical parameters of airway assessment, in many cases a difficult airway may be undiagnosed preoperatively and we may land up in a situation of can’t intubate, can’t ventilate during intubation and anaesthesia. During the last few years ultrasound has been widely used in the operating room for ultrasound-guided procedures such as nerve block or central venous access. Ultrasound provides quick, relatively easy, and accurate information, with diagnostic and therapeutic relevance. For some considerable time ultrasound has not been taken into consideration as a tool for the evaluation of the airway or as a predictor of difficult laryngoscopy. Pre-operative ultrasound measurement of the anterior neck soft-tissue thickness at different levels,combined with the commonly used screening tests and risk factor assessment for difficult laryngoscopy might improve the ability to predict difficult laryngoscopy. The ASA has included ultrasound in pre-operative airway assessment in its guidelines for the management of difficult airway 2022 and parameters included were skin-to-hyoid distance, tongue volume, and distance from the skin to the epiglottis. So, Ultrasonography is emerging as a new technique for difficult airway assessment as it is simple, convenient and non-invasive, has no risk of radiation exposure, and because it is portable, it can be used to assess airway bedside along with clinical parameters. Some studies are available to assess the usefulness of pre-operatively measured ultrasonographic airway parameters to predict difficult laryngoscopy and difficult tracheal intubation. A meta-analysis concluded that hyomental distance in a neutral head position was the most consistent pre-operative ultrasound measured airway parameter to predict difficult laryngoscopy and difficult tracheal intubation. |