High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029699
Collaborator
(none)
50
2
36

Study Details

Study Description

Brief Summary

This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning

Condition or Disease Intervention/Treatment Phase
  • Device: high flow nasal cannula
  • Device: non invasive positive pressure ventilation
N/A

Detailed Description

  • High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated and humidified medical gas at up to 60 L/min of flow and is considered to have a number of physiological effects: reduction of anatomical dead space, positive end expiratory pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification

  • Noninvasive positive-pressure ventilation is a safe and effective means of improving gas exchange in patients with many types of acute respiratory failure . for example, adding noninvasive ventilation to standard therapy decreased the need for endotracheal intubation...For patients assigned to noninvasive ventilation, the ventilator was connected with conventional tubing to a clear, full-face mask with an inflatable soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to 10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the disappearance of accessory muscle activity (as evaluated by palpation of the sternocleidomastoid muscle), and patient comfort

  • The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory failure (ARF) are controversial. The investigators aimed to further determine the effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing Reintubation in Mechanically Ventilated Patient
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: high flow nasal cannula group

patients put on high flow nasal cannula after extubation

Device: high flow nasal cannula
device are used for weaning patients after mechanical ventilation extubation

Active Comparator: non invasive positive pressure ventilation group

patients put on non invasive positive pressure ventilation group after extubation

Device: non invasive positive pressure ventilation
device are used for weaning patients after mechanical ventilation extubation

Outcome Measures

Primary Outcome Measures

  1. the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG ) [baseline]

Secondary Outcome Measures

  1. Duration of using of HFNC or NIPPV [up to 30 days]

  2. Length of hospital stay measured by days [up to 30 days]

  3. In - hospital mortality measured by number of died cases [up to 30 days]

  4. Adverse events [up to 30 days]

    Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)

  5. Incidence of any possible complications associated with the use of HFNC and NIPPV [up to 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning

  • Age >18 years old

Exclusion Criteria:
  • In patients less than 18 years old

  • Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx

  • Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Osman Shehata Abdelkareem, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06029699
Other Study ID Numbers:
  • HFNC vs NIPPV
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023