Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
Primary Purpose
COPD, Chronic Hypercapnic Respiratory Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
HOF
noninvasive mechanical ventilation (NIV)
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD patients
Eligibility Criteria
Inclusion Criteria:
- COPD patients
- Chronic hypercapnic respiratory failure (pH>7.34 and PaCO2>45 mmHg)
Exclusion Criteria:
- Cancer
- Neurological and cardiac disease
Sites / Locations
- San'Orsola Malpighi Hospital, Bologna ITALY
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
spontaneous breathing trial
HOF20
HOF30
noninvasive mechanical ventilation (NIV)
Arm Description
the patients will be asked to breathe spontaneously using their acutal low oxygen flow
the patients will be asked to breathe with HOF of 20 L/min
the patients will be asked to breathe with HOF of 30 L/min
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Outcomes
Primary Outcome Measures
recording of respiratory mechanics
Respiratory mechanics will be assessed using Mead and Wittenberger's technique.
Secondary Outcome Measures
dyspnea score
dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine
Full Information
NCT ID
NCT02363920
First Posted
February 3, 2015
Last Updated
October 8, 2016
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT02363920
Brief Title
Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
Official Title
Short Term Physiological Effects of Nasal High Oxygen Flow vs Low Oxygen Flow and Noninvasive Ventilation (NIV) on Respiratory Mechanics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients.
The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.
Detailed Description
Subjects. 10 in-patients with stable COPD and chronic hypercapnic respiratory failure with no history of neurological or chronic cardiac disease will be recruited. They need to be in a phase of clinical stability and were for a short period of rehabilitation. Patients with X-ray evidence of pulmonary edema or congestion and pulmonary infiltrate will be excluded from the study. Written consent will be obtained from all subjects, and the protocol will be approved by the Ethics Committee.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Hypercapnic Respiratory Failure
Keywords
COPD patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spontaneous breathing trial
Arm Type
Placebo Comparator
Arm Description
the patients will be asked to breathe spontaneously using their acutal low oxygen flow
Arm Title
HOF20
Arm Type
Active Comparator
Arm Description
the patients will be asked to breathe with HOF of 20 L/min
Arm Title
HOF30
Arm Type
Active Comparator
Arm Description
the patients will be asked to breathe with HOF of 30 L/min
Arm Title
noninvasive mechanical ventilation (NIV)
Arm Type
Active Comparator
Arm Description
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Intervention Type
Device
Intervention Name(s)
HOF
Intervention Description
the addition of high oxygen flow to patients breathing spontaneously
Intervention Type
Device
Intervention Name(s)
noninvasive mechanical ventilation (NIV)
Intervention Description
the addition of a ventilatory support delivered with a oro-nasal interface
Primary Outcome Measure Information:
Title
recording of respiratory mechanics
Description
Respiratory mechanics will be assessed using Mead and Wittenberger's technique.
Time Frame
30 minutes per arm
Secondary Outcome Measure Information:
Title
dyspnea score
Description
dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine
Time Frame
30 minutes per arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patients
Chronic hypercapnic respiratory failure (pH>7.34 and PaCO2>45 mmHg)
Exclusion Criteria:
Cancer
Neurological and cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava, md
Organizational Affiliation
Sant'Orsola Malpighi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San'Orsola Malpighi Hospital, Bologna ITALY
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
28104830
Citation
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.
Results Reference
derived
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Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
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