Elective Surgery, General Anesthesia
Conditions
Keywords
Airway management, Sniffing position, Ramp position, Tracheal intubation, Pillow height
Brief summary
The goal of this clinical trial is to find out whether the ramp position or sniffing position is better for endo tracheal intubation which provides better hemodynamic stability and short intubation time and good laryngoscopic view in regards of cormack lehane grading.
Detailed description
This randomized controlled trial will be conducted at the Shaheed Mohtarma Benazir Bhutto Institute of Trauma after obtaining approval from the College of Physicians and Surgeons of Pakistan (CPSP) and the Ethical Review Committee. The study will also be registered on ClinicalTrials.gov prior to participant enrollment. Participants will be allocated into two groups using computer-generated randomization. Group A will undergo tracheal intubation in the sniffing position using a fixed pillow height of 4 cm, while Group B will be positioned in the ramp position using a customized pillow height (4-8 cm) adjusted to achieve alignment of the external auditory meatus with the sternal notch. Allocation will be performed by the primary investigator prior to surgery. All patients will receive a standardized anesthesia protocol with continuous ASA monitoring. Induction of anesthesia will be achieved using propofol (2 mg/kg) and nalbuphine (0.15 mg/kg), followed by atracurium (0.5 mg/kg) after confirmation of adequate mask ventilation. Controlled positive pressure ventilation will be maintained for three minutes before direct laryngoscopy using a Macintosh laryngoscope. Laryngoscopy will be performed by the primary investigator, while a second anesthetist, blinded to the study objectives where feasible, will record procedural timings and hemodynamic parameters. Any adjuncts or optimization maneuvers used during intubation will be documented. Hemodynamic variables will be monitored at predefined intervals following intubation. The study will be conducted as an open-label trial. All patient data will be handled confidentially, and anonymization will be ensured during data collection, analysis, and reporting.
Interventions
DEVICEGroup A - Fixed Pillow
Fixed pillow height of 4 cm for laryngoscopy alignment
DEVICEGroup B - Customized Pillow
Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy.
Sponsors
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two groups: Group A (fixed pillow height of 4 cm) or Group B (customized pillow height 4-8 cm to align the external auditory meatus and sternal notch). The study will compare laryngoscopy view and intubation time between the two groups. Randomization is computer-generated, and all patients will undergo a standardized anesthesia protocol. Outcome data, including Cormack-Lehane grade, intubation time, and hemodynamic parameters, will be recorded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 60 years * ASA physical status I or II * Mallampati class I or II * Patients scheduled for elective surgery * BMI between 25 and 30 * Either gender
Exclusion criteria
* ASA physical status III or IV * Predicted difficult intubation (Mallampati class III or IV) * Maxillofacial trauma, tumors, or obvious malformations of the neck or face * Pregnancy * Unstable cervical spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Attempt Intubation Success Rate | During the procedure | Percentage of patients in whom successful intubation is achieved on the first attempt using the study device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 0, 3, and 5 minutes after intubation | Heart rate measured to assess physiological response to intubation. Units of Measure: Beats per minute (bpm) |
| Intubation Time | Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂) | Total time taken for successful endotracheal intubation, including multiple attempts if necessary. |
| Blood Pressure | 0, 3, and 5 minutes after intubation | Systolic and diastolic blood pressure measured to assess physiological response. Units of Measure: mmHg |
| Cormack-Lehane Grade | During laryngoscopy | Laryngeal view graded according to the Cormack-Lehane classification by the primary investigator. |
Countries
Pakistan
Contacts
STUDY_DIRECTORDr Zafar Mehdi, Fcps anaesthesiology
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Outcome results
None listed