NCT07506655

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 28, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 26, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Airway managementSniffing positionRamp positionTracheal intubationPillow height

Outcome Measures

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.

    During the procedure

Secondary Outcomes (4)

  • Heart Rate

    0, 3, and 5 minutes after intubation

  • Intubation Time

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

  • Blood Pressure

    0, 3, and 5 minutes after intubation

  • Cormack-Lehane Grade

    During laryngoscopy

Study Arms (2)

Group A - Fixed Pillow

EXPERIMENTAL

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

Device: Group A - Fixed Pillow

Group B - Customized Pillow

EXPERIMENTAL

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

Fixed pillow height of 4 cm for laryngoscopy alignment

Group A - Fixed Pillow

Pillow with adjustable height 4-8 cm to align external auditory meatus and sternal notch for laryngoscopy.

Group B - Customized Pillow

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

Study Officials

  • Dr Zafar Mehdi, Fcps anaesthesiology

    Shaheed Mohtarma Benazir Bhutto Institue of Trauma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2026

First Posted

April 2, 2026

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. Patient confidentiality, institutional policies, and local regulations regarding personal health information prevent sharing of the raw data.

Locations