Jan H Storre1, Elena Matrosovich2, Emelie Ekkernkamp3, David J Walker3, Claudia Schmoor4, Michael Dreher5, Wolfram Windisch6. 1. Department of Pneumology, Cologne-Merheim Hospital, Kliniken der Stadt Köln, Witten/Herdecke University Hospital, Cologne Department of Pneumology, University Hospital Freiburg, Freiburg storrej@kliniken-koeln.de. 2. Department of Pneumology, University Hospital Freiburg, Freiburg Department of Internal Medicine, Klinikum Nuremberg Nord, Nuremberg. 3. Department of Pneumology, University Hospital Freiburg, Freiburg. 4. Clinical Trials Unit, University Medical Center, Freiburg. 5. Department of Pneumology, University Hospital Freiburg, Freiburg Department of Cardiology, Pneumology, and Vascular Medicine, University Hospital, Aachen, Germany. 6. Department of Pneumology, Cologne-Merheim Hospital, Kliniken der Stadt Köln, Witten/Herdecke University Hospital, Cologne Department of Pneumology, University Hospital Freiburg, Freiburg.
Abstract
BACKGROUND:High-intensity noninvasive ventilation (HI-NIV) is the most effective means of improving several physiological and clinical parameters in subjects with chronic hypercapnic COPD. Whether the newer hybrid mode using target tidal volume noninvasive ventilation (target V(T) NIV) provides additional benefits remains unclear. METHODS:Subjects with COPD successfully established on long-term HI-NIV were switched to target V(T) NIV. Optimal target V(T) settings according to nocturnal transcutaneous P(CO2) measurements were achieved following a randomized crossover trial using 8 mL/kg ideal body weight and 110% of individual V(T) during HI-NIV, respectively. The following parameters were compared at the beginning of the trial while subjects were on HI-NIV, and after 3 months on optimal target V(T) NIV: sleep quality by polysomnography, overnight gas exchange, subjects' tolerance, overnight pneumotachygraphic measurements during NIV, health-related quality of life (severe respiratory insufficiency questionnaire), exercise capacity (6-min walk test), and lung function. RESULTS:Ten of 14 subjects completed the study. There were no differences between HI-NIV and target V(T) NIV in any of the above-mentioned parameters. Specifically, the mean overnight transcutaneous P(CO2) was equivalent under each form of ventilation (both 45 ± 5 mm Hg, P = .75). CONCLUSIONS:Switching subjects from well-established HI-NIV to target V(T) NIV shows no clinical benefits in chronic hypercapnic COPD. In particular, sleep quality, the control of nocturnal hypoventilation, daytime hypercapnia, overnight ventilation patterns, subjects' tolerance, health-related quality of life, lung function, and exercise capability were all similar in subjects who underwent HI-NIV and target V(T) NIV. Nevertheless, target V(T) NIV might offer some physiological advantages in breathing pattern and might be beneficial in some individual patients. (German Clinical Trials Register [www.drks.de] Registration DRKS00000450.).
RCT Entities:
BACKGROUND: High-intensity noninvasive ventilation (HI-NIV) is the most effective means of improving several physiological and clinical parameters in subjects with chronic hypercapnic COPD. Whether the newer hybrid mode using target tidal volume noninvasive ventilation (target V(T) NIV) provides additional benefits remains unclear. METHODS: Subjects with COPD successfully established on long-term HI-NIV were switched to target V(T) NIV. Optimal target V(T) settings according to nocturnal transcutaneous P(CO2) measurements were achieved following a randomized crossover trial using 8 mL/kg ideal body weight and 110% of individual V(T) during HI-NIV, respectively. The following parameters were compared at the beginning of the trial while subjects were on HI-NIV, and after 3 months on optimal target V(T) NIV: sleep quality by polysomnography, overnight gas exchange, subjects' tolerance, overnight pneumotachygraphic measurements during NIV, health-related quality of life (severe respiratory insufficiency questionnaire), exercise capacity (6-min walk test), and lung function. RESULTS: Ten of 14 subjects completed the study. There were no differences between HI-NIV and target V(T) NIV in any of the above-mentioned parameters. Specifically, the mean overnight transcutaneous P(CO2) was equivalent under each form of ventilation (both 45 ± 5 mm Hg, P = .75). CONCLUSIONS: Switching subjects from well-established HI-NIV to target V(T) NIV shows no clinical benefits in chronic hypercapnic COPD. In particular, sleep quality, the control of nocturnal hypoventilation, daytime hypercapnia, overnight ventilation patterns, subjects' tolerance, health-related quality of life, lung function, and exercise capability were all similar in subjects who underwent HI-NIV and target V(T) NIV. Nevertheless, target V(T) NIV might offer some physiological advantages in breathing pattern and might be beneficial in some individual patients. (German Clinical Trials Register [www.drks.de] Registration DRKS00000450.).
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