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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05190458
Collaborator
(none)
50
1
2
14
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Velocity Nasal Insufflation
  • Other: Non-invasive mechanical ventilation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome.
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Non-invasive mechanical ventilation (group A)

Patients will be Randomized into 2 subgroups by (1:1) crossover:- Group A will be put on NIMV Group B will be put on HVNI

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

Other: High Velocity Nasal Insufflation (group B)

Patients will be Randomized into 2 subgroups by (1:1) crossover:- Group A will be put on NIMV Group B will be put on HVNI

Other: High Velocity Nasal Insufflation
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of HVNI in correction of Acidosis . [Baseline]

    Evaluation of the effectiveness of HVNI in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).

  2. Evaluation of HVNI in correction of Hypercapnia. [Baseline]

    Evaluation of the effectiveness of HVNI in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)

Secondary Outcome Measures

  1. Evaluation of HVNI in management of respiratory failure. [Baseline]

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

Other Outcome Measures

  1. Evaluation of HVNI in correction of Hypoxemia. [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Respiratory ICU in Assiut University Hospitals Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Ashraf Z El-Abdeen Mohammed, Professor, Chest Diseases and Tuberculosis Department-Assiut University Hospitals
  • Study Chair: Lamiaa H Shaaban, Professor, Chest Diseases and Tuberculosis Department-Assiut University Hospitals
  • Study Chair: Waleed G Elddin Khaleel, Lecturer, Chest Diseases and Tuberculosis Department-Assiut University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abanoub Hany Sadek Farag, Resident Doctor at chest department-Assiut University Hospitals, Assiut University
ClinicalTrials.gov Identifier:
NCT05190458
Other Study ID Numbers:
  • HVNI in Overlap syndrome
First Posted:
Jan 13, 2022
Last Update Posted:
Feb 7, 2022
Last Verified:
Feb 1, 2022
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 Feb 7, 2022