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

Primary Purpose

Overlap Syndrome, Obesity Hypoventilation Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High Velocity Nasal Insufflation
Non-invasive mechanical ventilation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overlap Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory ICU in Assiut University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Non-invasive mechanical ventilation (group A)

High Velocity Nasal Insufflation (group B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2021
Last Updated
July 19, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05190458
Brief Title
Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome
Acronym
HVNI
Official Title
Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overlap Syndrome, Obesity Hypoventilation Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive mechanical ventilation (group A)
Arm Type
Other
Arm Description
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
Arm Title
High Velocity Nasal Insufflation (group B)
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High Velocity Nasal Insufflation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-invasive mechanical ventilation
Intervention Description
Noninvasive ventilation (NIV) refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube).
Primary Outcome Measure Information:
Title
Evaluation of HVNI in correction of Acidosis .
Description
Evaluation of the effectiveness of HVNI in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Time Frame
Baseline
Title
Evaluation of HVNI in correction of Hypercapnia.
Description
Evaluation of the effectiveness of HVNI in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Evaluation of HVNI in management of respiratory failure.
Description
Evaluation of the effectiveness of HVNI in management of respiratory failure through measurement of PO2 via arterial blood gases test (ABG)
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Evaluation of HVNI in correction of Hypoxemia.
Description
Evaluation of the effectiveness of HVNI in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abanoub H Sadek Farag, Resident
Phone
+201279269591
Email
Abanoubabanoubhanysadek@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Z El-Abdeen Mohammed, Professor
Organizational Affiliation
Chest Diseases and Tuberculosis Department-Assiut University Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lamiaa H Shaaban, Professor
Organizational Affiliation
Chest Diseases and Tuberculosis Department-Assiut University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Waleed G Elddin Khaleel, Lecturer
Organizational Affiliation
Chest Diseases and Tuberculosis Department-Assiut University Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Respiratory ICU in Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abanoub H Sadek Farag, Resident
Phone
+201279269591
Email
Abanoubabanoubhanysadek@outlook.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32273085
Citation
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.
Results Reference
background
PubMed Identifier
29310868
Citation
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.
Results Reference
background
PubMed Identifier
28282995
Citation
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.
Results Reference
background
PubMed Identifier
32061194
Citation
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.
Results Reference
background
PubMed Identifier
30872398
Citation
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.
Results Reference
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Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome

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