The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy

NCT06593509 | Completed FDA Device

• 1 other identifier: FMASU MS 443/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized controlled study enrolling sixty patients who fulfilled weaning criteria after requiring invasive MV. After extubation, patients were randomized into three groups (20 patients per group) :NIV group , HFNC group, and COT group. Primary outcomes included reintubation rates at certain time points and after 48 hours post-extubation while secondary outcomes included time to reintubation , ICU length of stay, ICU mortality. Objective: To compare the rate of reintubation within 48 hours after extubation among patients receiving NIV, HFNC and COT as post-extubation respiratory support.

Conditions

Post Extubation Respiratory Failure

Keywords

weaning.; Mechanical ventilation; COT; HFNC; NIV

Outcome Measures

Primary Outcomes (1)

• reintubation rate(N,%)

  reintubation after extubation

  48 hours

Secondary Outcomes (2)

• intensive care unit length of stay(days)

  one month

• intensive care unit mortality rate(N,%)

  one month

Study Arms (3)

Non-invasive mechanical ventilation

EXPERIMENTAL

Device: Non-invasive mechanical ventilation Bilevel pressure support through a face mask

Device: Maquet,Servo I.

High Flow Conditioned Oxygen Therapy

EXPERIMENTAL

Device: High Flow Conditioned Oxygen device vapotherm via nasal cannula

Device: Vapotherm

Conventional Oxygen Therapy

ACTIVE COMPARATOR

Device: Conventional Oxygen Therapy conventional Oxygen Therapy with Venturi facial mask.

Device: venturi mask

Interventions

Maquet,Servo I. DEVICE

Model number: 06487800, Serial Number: 19761, SKU#: Inv-00344191, Made in Sweden

Non-invasive mechanical ventilation

Vapotherm DEVICE

INC ,100 domain drive Exeter, NH 03833, Made in U.S.A

High Flow Conditioned Oxygen Therapy

venturi mask DEVICE

Intersurgical Ltd, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK.,REF. 1107085, LOT,31757961

Conventional Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (\> 18 years)
• who were mechanically ventilated longer than 12 hours for various respiratory indications
• and planned for liberation from MV after fulfilling the criteria for weaning

You may not qualify if:

• patients (\<18 years )
• Tracheostomized patients,
• patients who were self-extubated or accidentally extubated,
• Presence of contraindication to NIV : facial trauma, fracture or burn, pneumothorax, bronchopleural fistula, gastro/esophageal bleeding,
• and patients who refused to participate in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Respiratory intensive care unit , chest department faculty of medicine ain shams university

Cairo, 1181, Egypt

Location

Study Officials

• Emad Eldine A korraa, MD

  chest department ,ain shams university,cairo,egypt

  STUDY DIRECTOR

• Rehab M Mohammad, MD

  chest department ,ain shams university,cairo,egypt

  PRINCIPAL INVESTIGATOR

• amira AA elghonemy, M.B.B.Ch

  chest department ,ain shams university,cairo,egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)