Clinical Outcome of Endotracheal Intubation in Non-trauma... | NCT05795231

Studies
Clinical Outcome of Endotracheal Intubation in Non-trauma Patients

NCT05795231

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Jan 29, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Adverse Effects of Endotracheal Intubation

Interventions

Macintosh Laryngoscope Vs Video Laryngoscope

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Jan 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gender Based		Male patients will be compared to female patients with regards to incidence of complications	Device: Macintosh Laryngoscope Vs Video Laryngoscope
Age Based		Various age groups will be evaluated to determine vulnerable age groups	Device: Macintosh Laryngoscope Vs Video Laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macintosh Laryngoscope Vs Video Laryngoscope	Device	Evaluate incidence of first trial success and complications	Age Based Gender Based

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Events	Severe hypoxemia, Cardiac arrest, Cardiovascular collapse, Death	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Moderate Complications	Cardiac arrhythmia, Esophageal intubation, Aspiration, Dental injury, Difficulty intubation, Agitation	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who meet the required criteria and consent to the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University		Alexandria	Alexandria Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided