- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06924411
Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed A Hashem
- Phone Number: Resident +201100074625
- Email: Mohamed.hashem@med.sohag.edu.eg
Study Contact Backup
- Name: Fawzy A Badawy
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients ≥18 years old and indicated for intubation with variable presentations.
Exclusion Criteria:
- Patients unstable to be positioned in semi setting as spine trauma and polytraumatized patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Supine group
Intubation in supine position
|
Direct laryngoscopy intubation
|
|
Active Comparator: Ramped group
Intubation in ramped position
|
Direct laryngoscopy intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of First pass success
Time Frame: 6 months
|
Successful intubation from first trial
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Soh-Med-25-3-04MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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