- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795231
CLINICAL OUTCOME OF ENDOTRACHEAL INTUBATION IN NON-TRAUMA PATIENTS
March 21, 2023 updated by: Luther Martin Luther, Alexandria University
CLINICAL OUTCOME OF ENDOTRACHEAL INTUBATION IN NON-TRAUMA PATIENTS IN THE EMERGENCY DEPARTMENT OF ALEXANDRIA MAIN UNIVERSITY HOSPITAL
The study will involve all adult patients visiting the Alexandria University main hospitals' Emergency department for reasons other than trauma that will require assisted ventilation via endotracheal intubation.
Those pre-intubated or intubated post CPR will not be included.
The main aim is to evaluate the clinical outcome (complications) of emergency endotracheal intubation and to correlate the incidence and nature of complications associated with tracheal intubations to demographic data and patient characteristics.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Alexandria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who meet the required criteria and consent to the study.
Description
Inclusion Criteria:
- Adult patients of both sex with a life threatening impairment of the cardiovascular, respiratory or neurological system requiring emergency endotracheal intubation in the emergency department of Alexandria Main University Hospital.
Exclusion Criteria:
• Patients who are less than 18 years of age.
- Patients intubated out of the hospital.
- Trauma patients.
- Patients intubated for cardiac arrest.
- Failed intubation in the field
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gender Based
Male patients will be compared to female patients with regards to incidence of complications
|
Evaluate incidence of first trial success and complications
|
Age Based
Various age groups will be evaluated to determine vulnerable age groups
|
Evaluate incidence of first trial success and complications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Events
Time Frame: 24 hours
|
Severe hypoxemia, Cardiac arrest, Cardiovascular collapse, Death
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate Complications
Time Frame: 24 hours
|
Cardiac arrhythmia, Esophageal intubation, Aspiration, Dental injury, Difficulty intubation, Agitation
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AlexandriaU-LutherM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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