High Flow Nasal Cannula vs Noninvasive Ventilation in Pat... | NCT05527431

Studies
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma

NCT05527431

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jun 4, 2024Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Blunt Injury of Thorax

Interventions

high flow nasal cannula
noninvasive ventilation

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

Aug 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

Aug 1, 2022Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Aug 18, 2022

First Submission Date that Met QC Criteria

Aug 31, 2022

First Posted Date

Sep 2, 2022Actual

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

Jun 3, 2024

Last Update Posted Date

Jun 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to compare high flow nasal cannula against noninvasive ventilation in patients with non-sever blunt chest trauma in improvement of oxygenation, need for intubation and mechanical ventilation within 28 days

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high flow nasal cannula	Active Comparator		Device: high flow nasal cannula
noninvasive mechanical ventilation	Active Comparator		Device: noninvasive ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high flow nasal cannula	Device	high flow nasal cannula	high flow nasal cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PaO2/FiO2 ratio	mean value of three successive PaO2/FiO2 ratio in mmHg between both groups	3 successive days

Secondary Outcomes

Measure	Description	Time Frame
Discomfort score	Discomfort related to oxygen delivery devices will be evaluated using a 10- point numeric scale which low number is low discomfort.	3 successive days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 y,
Willing and able to provide written informed consent prior to performing study procedures,
currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) SpO2 90% or less while breathing 10 L/min.

Exclusion Criteria:

Contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker
intubation for any cause other than respiratory cause

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University hospitals		Cairo		11591	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

Intervention Browse Module

MeSH Terms

ID	Term
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided