Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure

A randomized trial

Jeremy E. Orr, John Martin Coleman III, Gerard J. Criner, Krishna M. Sundar, Sheila C. Tsai, Adam V. Benjafield, Maureen E. Crocker, Leslee Willes, Atul Malhotra, Robert L. Owens, Lisa F Wolfe*

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background and objective: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. Methods: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea–hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. Results: A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. Conclusion: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure.Clinical Trial Registration: NCT02683772 at clinicaltrials.gov.

Original languageEnglish (US)
JournalRespirology
DOIs
StatePublished - Jan 1 2019

Fingerprint

Respiratory Insufficiency
Noninvasive Ventilation
Pressure
Sleep
Hypoventilation
Neuromuscular Diseases
Aptitude
Treatment Failure
Cross-Over Studies
Chronic Obstructive Pulmonary Disease
Ventilation
Obesity
Gases
Clinical Trials
Oxygen

Keywords

  • chronic obstructive pulmonary disease
  • neuromuscular disease
  • non-invasive ventilation
  • obesity hypoventilation syndrome
  • respiratory failure

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Orr, Jeremy E. ; Coleman III, John Martin ; Criner, Gerard J. ; Sundar, Krishna M. ; Tsai, Sheila C. ; Benjafield, Adam V. ; Crocker, Maureen E. ; Willes, Leslee ; Malhotra, Atul ; Owens, Robert L. ; Wolfe, Lisa F. / Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure : A randomized trial. In: Respirology. 2019.
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abstract = "Background and objective: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4{\%} oxygen desaturation index (ODI4{\%}) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. Methods: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea–hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. Results: A total of 38 patients constituted the study population. Mean ODI4{\%} was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4{\%} across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. Conclusion: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure.Clinical Trial Registration: NCT02683772 at clinicaltrials.gov.",
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author = "Orr, {Jeremy E.} and {Coleman III}, {John Martin} and Criner, {Gerard J.} and Sundar, {Krishna M.} and Tsai, {Sheila C.} and Benjafield, {Adam V.} and Crocker, {Maureen E.} and Leslee Willes and Atul Malhotra and Owens, {Robert L.} and Wolfe, {Lisa F}",
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Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure : A randomized trial. / Orr, Jeremy E.; Coleman III, John Martin; Criner, Gerard J.; Sundar, Krishna M.; Tsai, Sheila C.; Benjafield, Adam V.; Crocker, Maureen E.; Willes, Leslee; Malhotra, Atul; Owens, Robert L.; Wolfe, Lisa F.

In: Respirology, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure

T2 - A randomized trial

AU - Orr, Jeremy E.

AU - Coleman III, John Martin

AU - Criner, Gerard J.

AU - Sundar, Krishna M.

AU - Tsai, Sheila C.

AU - Benjafield, Adam V.

AU - Crocker, Maureen E.

AU - Willes, Leslee

AU - Malhotra, Atul

AU - Owens, Robert L.

AU - Wolfe, Lisa F

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and objective: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. Methods: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea–hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. Results: A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. Conclusion: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure.Clinical Trial Registration: NCT02683772 at clinicaltrials.gov.

AB - Background and objective: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. Methods: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea–hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. Results: A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. Conclusion: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure.Clinical Trial Registration: NCT02683772 at clinicaltrials.gov.

KW - chronic obstructive pulmonary disease

KW - neuromuscular disease

KW - non-invasive ventilation

KW - obesity hypoventilation syndrome

KW - respiratory failure

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