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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Fixed Pillow | Experimental | Participants receive a fixed pillow height of 4 cm to align the head for laryngoscopy. |
|
| Group B - Customized Pillow | Experimental | Participants receive a customized pillow height of 4-8 cm to align the external auditory meatus and sternal notch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A - Fixed Pillow | Device | Fixed pillow height of 4 cm for laryngoscopy alignment |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Intubation Time | Total time taken for successful endotracheal intubation, including multiple attempts if necessary. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Zafar Mehdi, Fcps anaesthesiology | Shaheed Mohtarma Benazir Bhutto Institue of Trauma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaheed Mohtarma Benazir Bhutto | Karachi | Sindh | 74200 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32276812 | Background | 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. |
| Label | URL |
|---|---|
| Ramped versus sniffing position for endo tracheal intubation | View source |
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Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 7, 2025 | Mar 19, 2026 | Prot_SAP_ICF_000.pdf |
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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.
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| Group B - Customized Pillow | Device | Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy. |
|
| Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂) |
| Blood Pressure | Systolic and diastolic blood pressure measured to assess physiological response. Units of Measure: mmHg | 0, 3, and 5 minutes after intubation |
| Cormack-Lehane Grade | Laryngeal view graded according to the Cormack-Lehane classification by the primary investigator. | During laryngoscopy |