Comparison of Tracheal Intubation in Ramp vs Sniffing Position Using Customized vs Fixed Pillow

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Status: Invitation-only

Conditions: Elective Surgery; General Anesthesia

Treatments: Device: Group B - Customized Pillow; Device: Group A - Fixed Pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT07506655

IRB-000178/SMBBIT/Approval/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Group A - Fixed Pillow

Experimental group

Description:

Participants receive a fixed pillow height of 4 cm to align the head for laryngoscopy.

Treatment:

Device: Group A - Fixed Pillow

Group B - Customized Pillow

Experimental group

Description:

Participants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch.

Treatment:

Device: Group B - Customized Pillow