Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
NCT ID: NCT02363920
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2015-03-31
2016-09-30
Brief Summary
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The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.
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Detailed Description
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Measurements. Static and dynamic lung volumes assessed by body plethysmography (MasterLab-Jaeger, Hochberg, Germany).
Flow measured with a pneumotachograph (Screenmate Box 0586, Jaeger GmbH, Hochberg, Germany), connected to a rigid mouthpiece.
Airway pressure measured through tubing inserted in the mouthpiece and connected to a differential pressure transducer (Honeywell 300 cm H2O, Freeport, IL, USA). VT obtained by integration of the flow signal. The inspiratory (TI), expiratory (TE) and total breathing cycle (TTOT) duration, respiratory frequency (RR), and duty cycle (TI/TTOT) calculated as average values of 10 consecutive breaths, after 5 minutes of breathing.
Baseline from peak changes in esophageal (Pes), gastric (Pga), and transdiaphragmatic (Pdi) pressures measured using the balloon-catheter technique. Pressure at the airway opening (Paw) measured via a side port.
Respiratory mechanics will be assessed using Mead and Wittenberger's technique. Inspiratory pulmonary resistance (R,L) and elastance (E,L) calculated by fitting the equation of motion of a single-compartment model using multilinear regression.
Dynamic PEEPi (PEEPi,dyn) will be measured according to Appendini et al. The pressure time integrals of the diaphragm and the other inspiratory muscles calculated per breath (PTPdi/b and PTPes/b, respectively) and per minute (PTPdi/min and PTPes/min).
Subjective ratings of dyspnea assessed during the various trials using Borg's scale.
Arterial blood gases (ABGs) measured in samples taken from the radial artery (ABL 550 Radiometer, Copenhagen, Denmark).
The above mentioned variables, excluding arterial blood gases recorded after 15 minutes of spontaneous breathing. At the end of this part of the study, the patients will undergo a randomized 30' trial of: 1) non-invasive mechanical ventilation (NIMV) through a nose mask for 20 minutes while they were in a sitting position. The following pressures will be used: 14 cmH2O of inspiratory aid and 4 cmH2O of expiratory-positive airway pressure. 2) HOF at the flow of 20 L/min 3) HOF at the flow of 30 L/min ECG, SaO2 will be continuosly recorded All signals collected using a personal computer equipped with an A/D board, and stored at a sampling rate of 100 Hz. The mean value of each physiological variable during the 5 minutes of recording used for analyses. Results presented as mean + standard deviation (SD). Differences between physiological parameters recorded in the 3 settings will be analysed by paired Student's T-test. Pearson's coefficient will be used to calculate to assess correlation between variables. A p value \<0.05 chosen as the threshold of statistical significance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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spontaneous breathing trial
the patients will be asked to breathe spontaneously using their acutal low oxygen flow
HOF
the addition of high oxygen flow to patients breathing spontaneously
noninvasive mechanical ventilation (NIV)
the addition of a ventilatory support delivered with a oro-nasal interface
HOF20
the patients will be asked to breathe with HOF of 20 L/min
HOF
the addition of high oxygen flow to patients breathing spontaneously
noninvasive mechanical ventilation (NIV)
the addition of a ventilatory support delivered with a oro-nasal interface
HOF30
the patients will be asked to breathe with HOF of 30 L/min
HOF
the addition of high oxygen flow to patients breathing spontaneously
noninvasive mechanical ventilation (NIV)
the addition of a ventilatory support delivered with a oro-nasal interface
noninvasive mechanical ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
HOF
the addition of high oxygen flow to patients breathing spontaneously
noninvasive mechanical ventilation (NIV)
the addition of a ventilatory support delivered with a oro-nasal interface
Interventions
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HOF
the addition of high oxygen flow to patients breathing spontaneously
noninvasive mechanical ventilation (NIV)
the addition of a ventilatory support delivered with a oro-nasal interface
Eligibility Criteria
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Inclusion Criteria
* Chronic hypercapnic respiratory failure (pH\>7.34 and PaCO2\>45 mmHg)
Exclusion Criteria
* Neurological and cardiac disease
18 Years
85 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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dr. Stefano Nava
Chief of Respiratory and Critical care Unit
Principal Investigators
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stefano nava, md
Role: PRINCIPAL_INVESTIGATOR
Sant'Orsola Malpighi Hospital
Locations
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San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, , Italy
Countries
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References
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Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.
Other Identifiers
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402015
Identifier Type: -
Identifier Source: org_study_id
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