Intubation ComplicationsNCT06924411
Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
A study testing Direct Intubation in people with Intubation Complications, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation Complications
- What is being tested?
- Direct Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients ≥18 years old and indicated for intubation with variable presentations.
Who cannot join
- Patients unstable to be positioned in semi setting as spine trauma and polytraumatized patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fawzy A Badawy contact
About this 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.
Read more
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
- Being tested
- Direct Intubation
- Keywords
- Ramped intubation, Non-supine intubation, Semi-setting intubation, Intubation without aspiration, Ramped versus supine intubation, Intubation with less complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct IntubationDevice
Direct laryngoscopy intubation
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Active comparator | Intubation in supine position Receives: Device: Direct Intubation |
| Ramped group | Active comparator | Intubation in ramped position Receives: Device: Direct Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of First pass success
Successful intubation from first trial
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aly Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924411
- Sponsor's protocol ID
- Soh-Med-25-3-04MS
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT06924411
- Acronym / sponsor ID
- Soh-Med-25-3-04MS
- Conditions
- Intubation Complications
- Keywords
- Ramped intubation, Non-supine intubation, Semi-setting intubation, Intubation without aspiration, Ramped versus supine intubation, Intubation with less complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | Active comparator | Device: Direct IntubationIntubation in supine position |
| Ramped group | Active comparator | Device: Direct IntubationIntubation in ramped position |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients ≥18 years old and indicated for intubation with variable presentations.
Key exclusion criteria (1 listed)
- Patients unstable to be positioned in semi setting as spine trauma and polytraumatized patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct IntubationDirect laryngoscopy intubation | Device | Ramped group, Supine group |
Primary outcome
Number of First pass success
Time frame: 6 months
Successful intubation from first trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fawzy A Badawy contact
Questions about this trial
What is this clinical trial studying?
A study testing Direct Intubation in people with Intubation Complications, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Hashem (+201100074625 ext. Resident, Mohamed.hashem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of First pass success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.