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Enrolling by invitationNCT07506655Updated Sep 16, 2026

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

An interventional study of Group A - Fixed Pillow and Group B - Customized Pillow in Elective Surgery and General Anesthesia, sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Elective Surgery
  • General Anesthesia

Keywords

  • Airway management
  • Sniffing position
  • Ramp position
  • Tracheal intubation
  • Pillow height
03

In context

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma is the lead sponsor of 12 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (estimated)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. First-Attempt Intubation Success Rate

    Percentage of patients in whom successful intubation is achieved on the first attempt using the study device.

    Time frame: During the procedure

Secondary outcomes

  1. Heart Rate

    Heart rate measured to assess physiological response to intubation. Units of Measure: Beats per minute (bpm)

    Time frame: 0, 3, and 5 minutes after intubation

  2. Intubation Time

    Total time taken for successful endotracheal intubation, including multiple attempts if necessary.

    Time frame: Measured during the procedure (from laryngoscope insertion to confirmation via end-tidal CO₂)

  3. Blood Pressure

    Systolic and diastolic blood pressure measured to assess physiological response. Units of Measure: mmHg

    Time frame: 0, 3, and 5 minutes after intubation

  4. Cormack-Lehane Grade

    Laryngeal view graded according to the Cormack-Lehane classification by the primary investigator.

    Time frame: During laryngoscopy

07

Study locations

1 site
  • Shaheed Mohtarma Benazir Bhutto
    Karachi, Sindh 74200, Pakistan
08

References and documents

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. PubMed 32276812 ↗

Study documents

  • Protocol, analysis plan and consent form · Jul 7, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07506655
Lead sponsor
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Responsible party
Shafaq Memon (Principal Investigator, Shaheed Mohtarma Benazir Bhutto Institue of Trauma) — Principal investigator
First posted
Apr 2, 2026
Start date
Jan 1, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Dr Zafar Mehdi, Fcps anaesthesiology
study director · Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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