NCT05190458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

October 17, 2021

Last Update Submit

July 19, 2022

Conditions

Overlap SyndromeObesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (2)

  • Evaluation of HVNI in correction of Acidosis .

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

    Baseline

  • Evaluation of HVNI in correction of Hypercapnia.

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

    Baseline

Secondary Outcomes (1)

  • Evaluation of HVNI in management of respiratory failure.

    Baseline

Other Outcomes (1)

  • Evaluation of HVNI in correction of Hypoxemia.

    Baseline

Study Arms (2)

Non-invasive mechanical ventilation (group A)

OTHER

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

High Velocity Nasal Insufflation (group B)

OTHER

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

Interventions

High Velocity Nasal InsufflationOTHER

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.

High Velocity Nasal Insufflation (group B)
Non-invasive mechanical ventilationOTHER

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

Non-invasive mechanical ventilation (group A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory ICU in Assiut University Hospitals

Asyut, 71515, Egypt

Location

Related Publications (5)

  • Doshi PB, Whittle JS, Dungan G 2nd, Volakis LI, Bublewicz M, Kearney J, Miller TL, Dodge D, Harsch MR, DeBellis R, Chambers KA. The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis. Heart Lung. 2020 Sep-Oct;49(5):610-615. doi: 10.1016/j.hrtlng.2020.03.008. Epub 2020 Apr 6.

    PMID: 32273085BACKGROUND

  • Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.

    PMID: 29310868BACKGROUND

  • Poh TY, Mac Aogain M, Chan AK, Yii AC, Yong VF, Tiew PY, Koh MS, Chotirmall SH. Understanding COPD-overlap syndromes. Expert Rev Respir Med. 2017 Apr;11(4):285-298. doi: 10.1080/17476348.2017.1305895. Epub 2017 Mar 24.

    PMID: 28282995BACKGROUND

  • Orr JE, Schmickl CN, Edwards BA, DeYoung PN, Brena R, Sun XS, Jain S, Malhotra A, Owens RL. Pathogenesis of obstructive sleep apnea in individuals with the COPD + OSA Overlap syndrome versus OSA alone. Physiol Rep. 2020 Feb;8(3):e14371. doi: 10.14814/phy2.14371.

    PMID: 32061194BACKGROUND

  • Masa JF, Pepin JL, Borel JC, Mokhlesi B, Murphy PB, Sanchez-Quiroga MA. Obesity hypoventilation syndrome. Eur Respir Rev. 2019 Mar 14;28(151):180097. doi: 10.1183/16000617.0097-2018. Print 2019 Mar 31.

    PMID: 30872398BACKGROUND

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ashraf Z El-Abdeen Mohammed, Professor

    Chest Diseases and Tuberculosis Department-Assiut University Hospitals

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Central Study Contacts

Abanoub H Sadek Farag, Resident

CONTACT

+201279269591Abanoubabanoubhanysadek@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor at chest department-Assiut University Hospitals

Study Record Dates

First Submitted

October 17, 2021

First Posted

January 13, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

EG(1)