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Clinical Trials/NCT06593509
NCT06593509CompletedNot Applicable

The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy in Patients Weaned from Invasive Mechanical Ventilation:

Ain Shams University1 site in 1 country60 target enrollmentStarted: September 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
reintubation rate(N,%)

Study Overview

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.

Detailed Description

Reintubation after liberation from mechanical ventilation (MV) is a wellknown adverse event seen in different patients subtypes(post surgical, trauma,medical) as well as in surgical and medical intensive care units (ICUs) .The cumulative probability of reintubation , following planned and unplanned extubation , in 185 ICUs in the United States ,reached up to 10 % and 90% occurred within the first 96 hours (4 days) after first extubation , the median time to reintubation was 15 hours.

Proper timing for extubation is crucial to minimize extubation failure and about 12 to 14% of patients planned for extubation would require reintubation within 48 to 72 hours, mostly within the first 24 hours & in a multivariate analysis, duration of MV more than 7 days prior to extubation, ineffective cough, and severe systolic left ventricular dysfunction were independent factors associated with extubation failure, whereas ,in another study,age and underlying diseases were other factors associated with higher extubation failure with rates reaching up to 34% in patients 65 yrs or older, those with chronic respiratory or cardiac disorders and the condition was specifically associated with significant rapid clinical deterioration and worsening of daily organ dysfunction scores reflecting a direct effect of reintubation on patient outcomes. Mortality risk is reported to be five times higher in patients who require reintubation after extubation from MV.

Postextubation sequential oxygen devices applied as first-line therapy after extubation include noninvasive ventilation (NIV) , high-flow nasal cannula (HFNC) and conventional oxygen therapy (COT).

COT delivered via masks and nasal prongs has been widely used as the main sequential supportive oxygen therapy administered to patients after extubation . However, the maximal oxygen flow rates that these devices can deliver are limited with maximum flow rate up to 15 L/min only, which is usually far lower than the demands that postextubation patients would require . The fraction of inspired oxygen (FiO2) delivered by COT is unstable because of the entertainment of room air and dilution of the inspired oxygen .

Potential benefits of NIV include the ability to provide a relatively consistent and wider range of FiO2 compared with COT . Moreover, NIV creates an extrinsic positive end expiratory pressure which aids in recruitment of collapsed alveoli.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

open label

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

Non-invasive mechanical ventilation

Experimental

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

Intervention: Maquet,Servo I. (Device)

High Flow Conditioned Oxygen Therapy

Experimental

Device: High Flow Conditioned Oxygen device vapotherm via nasal cannula

Intervention: Vapotherm (Device)

Conventional Oxygen Therapy

Active Comparator

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

Intervention: venturi mask (Device)

Outcomes

Primary Outcomes

reintubation rate(N,%)

Time Frame: 48 hours

reintubation after extubation

Secondary Outcomes

  • intensive care unit length of stay(days)(one month)
  • intensive care unit mortality rate(N,%)(one month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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