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Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome

Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05190458
Acronym
HVNI
Enrollment
50
Registered
2022-01-13
Start date
2023-03-31
Completion date
2024-06-30
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overlap Syndrome, Obesity Hypoventilation Syndrome

Brief summary

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome. This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with obesity hypoventilation syndrome and overlap syndrome.

Detailed description

Overlap syndrome (OVS) is the concurrence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), and is associated with poor outcomes. COPD and obstructive sleep apnoea (OSA) are highly prevalent and different clinical COPD phenotypes that influence the likelihood of comorbid OSA. The increased lung volumes and low body mass index (BMI) associated with the predominant emphysema phenotype protects against OSA whereas the peripheral oedema and higher BMI often associated with the predominant chronic bronchitis phenotype promote OSA. The diagnosis of OSA in COPD patients requires clinical awareness and screening questionnaires which may help identify patients for overnight study. Management of OSA-COPD overlap patients differs from COPD alone and the survival of overlap patients treated with nocturnal positive airway pressure is superior to those untreated. high flow nasal cannula (HFNC), which delivers heated, humidified oxygen via a nasal cannula at high flow rates of up to 60 L/min, delivering a maximum of 100% oxygen, has been shown to be effective in the treatment of respiratory failure. High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with obesity hypoventilation syndrome and overlap syndrome. This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with overlap syndrome.

Interventions

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome.

Noninvasive ventilation (NIV) refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube).

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with respiratory failure in obesity hypoventilation syndrome and overlap syndrome, requiring ICU admission and fulfill criteria of NIMV supplementation (GOLD criteria 2021) * patients with obesity hypoventilation syndrome and overlap syndrome diagnosed by polysomnogram or through STOP BANG Questionnaire or EPWORTH Sleepness Scale.

Exclusion criteria

* Patients less than 18 years old * Patients with hemodynamic instability * Patients with central causes of hypercapnic respiratory failure * Patients with disturbed conscious level * Patients who refuse to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of HVNI in correction of Acidosis .BaselineEvaluation of the effectiveness of HVNI in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Evaluation of HVNI in correction of Hypercapnia.BaselineEvaluation of the effectiveness of HVNI in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)

Secondary

MeasureTime frameDescription
Evaluation of HVNI in management of respiratory failure.BaselineEvaluation of the effectiveness of HVNI in management of respiratory failure through measurement of PO2 via arterial blood gases test (ABG)

Other

MeasureTime frameDescription
Evaluation of HVNI in correction of Hypoxemia.BaselineEvaluation of the effectiveness of HVNI in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.

Countries

Egypt

Contacts

Primary ContactAbanoub H Sadek Farag, Resident
Abanoubabanoubhanysadek@outlook.com+201279269591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026