CLINICAL OUTCOME OF ENDOTRACHEAL INTUBATION IN NON-TRAUMA PATIENTS

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05795231
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
To Evaluate the Clinical Outcome (Complications) of Emergency Endotracheal Intubation in Non-traumatic Patients	Device: Macintosh Laryngoscope Vs Video Laryngoscope

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CLINICAL OUTCOME OF ENDOTRACHEAL INTUBATION IN NON-TRAUMA PATIENTS IN THE EMERGENCY DEPARTMENT OF ALEXANDRIA MAIN UNIVERSITY HOSPITAL
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Dec 30, 2022
• Actual Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Gender Based Male patients will be compared to female patients with regards to incidence of complications	Device: Macintosh Laryngoscope Vs Video Laryngoscope; Evaluate incidence of first trial success and complications
Age Based Various age groups will be evaluated to determine vulnerable age groups	Device: Macintosh Laryngoscope Vs Video Laryngoscope; Evaluate incidence of first trial success and complications

Outcome Measures

Primary Outcome Measures

1. Major Adverse Events [24 hours]

   Severe hypoxemia, Cardiac arrest, Cardiovascular collapse, Death

Secondary Outcome Measures

1. Moderate Complications [24 hours]

   Cardiac arrhythmia, Esophageal intubation, Aspiration, Dental injury, Difficulty intubation, Agitation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luther Martin Luther, Resident, Alexandria University
• ClinicalTrials.gov Identifier: NCT05795231
• Other Study ID Numbers: AlexandriaU-LutherM
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Apr 3, 2023