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NCT Number: NCT06029699

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

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

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Key information

Conditions

Respiratory Failure Re-intubation Rate Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

Device

device are used for weaning patients after mechanical ventilation extubation

non invasive positive pressure ventilation

Device

device are used for weaning patients after mechanical ventilation extubation

Primary outcomes

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

    Time frame: baseline

Secondary outcomes

  1. Duration of using of HFNC or NIPPV

    Time frame: up to 30 days

  2. Length of hospital stay measured by days

    Time frame: up to 30 days

  3. In - hospital mortality measured by number of died cases

    Time frame: up to 30 days

  4. Adverse events

    Time frame: 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

    Time frame: up to 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Kamel Ghanem, professor

CONTACT

[email protected]

+201227694434

mohamed osman shehata abdelkareem, resident doctor

CONTACT

[email protected]

+201123368743

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing Reintubation in Mechanically Ventilated Patient

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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