Comparison of Tracheal Intubation in Ramp vs Sniffing Position Using Customized vs Fixed Pillow
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group A - Fixed Pillow, Group B - Customized Pillow.
- Who it may be relevant to
- Registry conditions: Elective Surgery, General Anesthesia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Hemodynamic Stability and Intubation Timings and Cormack-Lehane Grading in Ramp Position Versus Sniffing Position
Overview
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
- Device Group A - Fixed Pillow
Fixed pillow height of 4 cm for laryngoscopy alignment - Device Group B - Customized Pillow
Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy.
Primary outcome measures
- First-Attempt Intubation Success Rate [Time frame: During the procedure]
Secondary outcome measures (4)
- Heart Rate [Time frame: 0, 3, and 5 minutes after intubation]
- Intubation Time [Time frame: Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂)]
- Blood Pressure [Time frame: 0, 3, and 5 minutes after intubation]
- Cormack-Lehane Grade [Time frame: During laryngoscopy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Pakistan · 1 center
- Shaheed Mohtarma Benazir Bhutto — Karachi
Publications
- Okada Y, Nakayama Y, Hashimoto K, Koike K, Watanabe N. Ramped versus sniffing position for tracheal intubation: A systematic review and meta-analysis. Am J Emerg Med. 2021 Jun;44:250-256. doi: 10.1016/j.ajem.2020.03.058. Epub 2020 Apr 1. PMID 32276812
Identifiers
NCT: NCT07506655 · IRB-000178/SMBBIT/Approval/25