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

Comparison of Hemodynamic Stability and Intubation Timings and Cormack-Lehane Grading in Ramp Position Versus Sniffing Position

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: General Anesthesia; Elective Surgery
• Intervention / Treatment: Device: Group A - Fixed Pillow; Device: Group B - Customized Pillow

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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Shaheed Mohtarma Benazir Bhutto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Fixed Pillow; Participants receive a fixed pillow height of 4 cm to align the head for laryngoscopy.	Device: Group A - Fixed Pillow; Fixed pillow height of 4 cm for laryngoscopy alignment
Experimental: Group B - Customized Pillow; Participants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch.	Device: Group B - Customized Pillow; Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-Attempt Intubation Success Rate	Percentage of patients in whom successful intubation is achieved on the first attempt using the study device.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack-Lehane Grade	Laryngeal view graded according to the Cormack-Lehane classification by the primary investigator.	During laryngoscopy
Intubation Time	Total time taken for successful endotracheal intubation, including multiple attempts if necessary.	Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂)
Heart Rate	Heart rate measured to assess physiological response to intubation. Units of Measure: Beats per minute (bpm)	0, 3, and 5 minutes after intubation
Blood Pressure	Systolic and diastolic blood pressure measured to assess physiological response. Units of Measure: mmHg	0, 3, and 5 minutes after intubation

Collaborators and Investigators

• Sponsor: Shaheed Mohtarma Benazir Bhutto Institue of Trauma
• Investigators: Study Director: Dr Zafar Mehdi, Fcps anaesthesiology, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Publications and helpful links

General Publications

• Okada Y. Nakayama Y. Hashirnoto K, Koike K, Watanabe N. Ramped versus sniffing position ibr tracheal,/ intulrirtion: A systcrnatic revierv aod rncta-analysis, Ant J llmerg Mctl. 2021 ;44:250- 6.

Helpful Links

• Ramped versus sniffing position for endo tracheal intubation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tracheal intubation; Airway management; Sniffing position; Ramp position; Pillow height
• Other Study ID Numbers: IRB-000178/SMBBIT/Approval/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No