Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study

NCT06924411 | Not Yet Recruiting

• 1 other identifier: Soh-Med-25-3-04MS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endotracheal intubation is a life saving procedure for critically unwell and injured patients presenting to the emergency department. Prolonged time to successful intubation and multiple failed attempts are associated with a higher incidence of life-threatening adverse events such as hypoxia and hypotension. Optimal head and neck positioning and clinical experience are important factors for successful endotracheal intubation in patients especially with a difficult airway. This study aims to investigate the rate of successful endotracheal intubation between ramped and supine positions in patients planned for intubation. The ramped position, where the bed is kept half-flat and the head is elevated up to 35°, is planned to prove that it improves glottic view and facilitate intubation and ventilation. Varying bed angles and heights during ramped position intubation may explain conflicting evidence regarding the effect of ramped position on intubation success in acute care settings. Therefore, it seems that finding a simple alternative method for the classic supine technique that can create conditions like the proposed standard conditions for laryngoscopy would be a suitable solution for intubating patients with higher difficulty. The patient's anatomy and the technique employed for laryngoscopy have a significant effect on the laryngeal view. The technique itself is influenced by a variety of factors including the laryngoscopic force and the skills, experience, and training of the physicians.

Conditions

Intubation Complications

Keywords

Ramped intubation; Non-supine intubation; Semi-setting intubation; Intubation without aspiration; Ramped versus supine intubation; Intubation with less complications

Outcome Measures

Primary Outcomes (1)

• Number of First pass success

  Successful intubation from first trial

  6 months

Study Arms (2)

Supine group

ACTIVE COMPARATOR

Intubation in supine position

Device: Direct Intubation

Ramped group

ACTIVE COMPARATOR

Intubation in ramped position

Device: Direct Intubation

Interventions

Direct Intubation DEVICE

Direct laryngoscopy intubation

Ramped group; Supine group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients ≥18 years old and indicated for intubation with variable presentations.

You may not qualify if:

• Patients unstable to be positioned in semi setting as spine trauma and polytraumatized patients.

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

Mohamed A Hashem

CONTACT

+201100074625; Mohamed.hashem@med.sohag.edu.eg

Fawzy A Badawy

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04