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

Obesity Hypoventilation Syndrome Clinical Trial

— HVNI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05190458
• Other study ID #: HVNI in Overlap syndrome
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: Abanoub H Sadek Farag, Resident
• Phone: +201279269591
• Email: Abanoubabanoubhanysadek[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity Hypoventilation Syndrome
• Overlap Syndrome
• Respiratory Insufficiency
• Syndrome
• Undifferentiated Connective Tissue Diseases

Intervention

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.
• 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).

Locations

Country	Name	City	State
Egypt	Respiratory ICU in Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View Citation

Masa JF, Pépin JL, Borel JC, Mokhlesi B, Murphy PB, Sánchez-Quiroga MÁ. Obesity hypoventilation syndrome. Eur Respir Rev. 2019 Mar 14;28(151). pii: 180097. doi: 10.1183/16000617.0097-2018. Print 2019 Mar 31. Review. — View 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. — View Citation

Poh TY, Mac Aogáin 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of HVNI in correction of Hypoxemia.	Evaluation of the effectiveness of HVNI in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.	Baseline
Primary	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
Primary	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	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)	Baseline