| CTRI Number |
CTRI/2024/12/078137 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ease of mask ventilation and tracheal intubation using Videolaryngoscope in Sniffing Versus Head Elevated Laryngoscopy Position for Elective Surgery Under General Anaesthesia A Randomised Controlled Trial |
|
Scientific Title of Study
|
Evaluation of the ease of mask ventilation and tracheal intubation using videolaryngoscope in sniffing versus head elevated laryngoscopy position in patients undergoing elective surgery under general endotracheal anaesthesia : A randomised controlled 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 |
Sanskriti Pandey |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BATHINDA |
| Address |
Anestheisa department AIIMS bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
08821006006 |
| Fax |
|
| Email |
sanskritipandeycims16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Associate Professor Department of Anesthesia AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate Proessor |
| Affiliation |
AIIMS Bathinda |
| Address |
Associate Professor Department of Anesthesia AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9968583915 |
| Fax |
|
| Email |
doctorjyotisharma@yahoo.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda Mandi Dabwali Road, Bathinda
Punjab-151001 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Sanskriti Pandey |
AIIMS Bathinda |
Anestheisa department AIIMS bathinda
Bathinda
PUNJAB |
08821006006
sanskritipandeycims16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Sniffing position
|
Group A patients’ head will be flexed at the level of the cervical spine and extended at the level
of the atlantooccipital joint during preoxygenation and endotracheal intubation for 5 minutes
|
| Comparator Agent |
Group B Head elevated laryngoscopy position |
Group B patients, a preformed ramped pillow (72cm x 14cm with 30 degrees angle) is placed
under patients head and back during preoxygenation and endotracheal intubation for 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, aged 18 to 65 years, with ASA physical status I, II, or III, undergoing elective surgery under general endotracheal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients refusal of consent
pregnancy
patient with suspected or established cervical spine injury
patient with BMI more then thirty five kg/metre square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the ease of mask ventilation and tracheal intubation between
sniffing and HELP using Han’s Mask Ventilation Classification and Description Scale and
Percentage of Glottis Opening (POGO) respectively |
intraoperative - 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare time to intubate between sniffing position & HELP
To compare the frequency of use of airway adjuncts or requirement to change the equipment between
the two groups
To compare the incidence of any adverse airway event (oxygen desaturation, bronchospasm) between
the two groups |
AT Baseline Intraoperative
Placement of endotracheal tube in trachea with bilateral equal air entries on both sides
of chest & appearance of capnographic waveforms in EtCO2 monitor. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/12/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to compare two positioning techniques for endotracheal intubation under general anesthesia.
### Procedure Summary: 1. **Enrollment & Consent**: After enrolling, patients will receive an information sheet and a verbal explanation of the study. Written informed consent will be obtained in the patient’s preferred language. 2. **Preoperative Setup**: ASA standard monitors will be applied, and baseline vital signs (heart rate, blood pressure, oxygen saturation) will be recorded. An intravenous (IV) line will be inserted.
3. **Positioning:** - **Group A**: Patients’ heads will be placed in the "sniffing position" (flexed at the cervical spine and extended at the atlantooccipital joint). - **Group B**: A preformed ramped pillow (72cm x 14cm, with a 30-degree angle) will be placed under the head and back, ensuring the alignment of the external auditory meatus and sternal notch in the same plane.
4. **Preoxygenation & Anesthesia Induction**: Preoxygenation will be done with 100% oxygen at 10 l/min for 3 minutes. Induction of anesthesia will involve midazolam (0.02 mg/kg), fentanyl (2 mcg/kg), and propofol (2 mg/kg), with ventilation checked before administering vecuronium (0.1 mg/kg). Mask ventilation will be performed using the one-handed E-C grip technique.
5. **Intubation Process**: Videolaryngoscopy will be performed using a NISCOMED version 2.0 Macintosh blade. Laryngeal visualization will be assessed with the POGO score (ranging from 0% to 100%, with 100% indicating complete visualization of the larynx). The time to intubate will be measured from the insertion of the videolaryngoscope until the sustained appearance of capnographic waveform (indicating successful endotracheal tube placement).
6. **Outcome Measures**: - POGO score will be recorded to assess laryngeal visualization. - The number of intubation attempts and the use of any additional equipment (e.g., oropharyngeal airway, alternative blades) will be documented. - Time to intubate will be measured from insertion of the videolaryngoscope until sustained capnography waveforms are observed.
7. **End Point**: The successful placement of the endotracheal tube, confirmed by bilateral equal air entry and the appearance of a capnographic waveform on the EtCO2 monitor.
This study is designed to evaluate the effectiveness and ease of two different positioning methods in facilitating successful and efficient intubation. |