Ignite Creation Date:
2024-05-06 @ 9:00 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02875379
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2015-07-27
Brief Title:
Clinical Comparison of Different Humidification Strategies During Noninvasive Ventilation With Helmet
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Clinical Comparison of Different Humidification Strategies During Noninvasive Ventilation With Helmet
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Non invasive positive pressure ventilation NIV is among first line treatments of acute respiratory failure Several interfaces are available for non-invasive ventilationDespite full face and oronasal masks are more frequently used some evidence suggests that helmets may optimize patients comfort and NIV tolerability
During NIV humidification strategies heat and moisture exchangers HME or heated humidifiers HH may significantly affect patients comfort and work of breathing
Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome
However the higher dead space ie 18 Lmin and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting
The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure in terms of comfort work of breathing and patient-ventilator interaction
Methods All awake collaborative hypoxemic patients requiring mechanical ventilation will be considered for the enrollment Hypercapnic patients iePaCO245 mmHg will be excluded
Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order Each period will last 60 minutes
Passive humidification double tube circuit
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 33C
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 37C
Passive humidification with HME Y-piece circuit
Ventilatory settings Draeger Evita xl or Evita infinity ventilators
Pressure support ventilation pressure support20 cmH20 FiO2 titrated to obtain SpO2 between 92 and 98 positive end-expiratory pressure10 cmH2O maximum inspiratory time 09 seconds inspiratory flow trigger 2 lmin expiratory trigger 30 of the maximum inspiratory flow pressurization time000 s
Such settings will be kept unchanged during the whole study period An oesophageal catheter will be placed and secured to measure oesophageal pressure Pes and gastric pressure Pga Nutrivent Italy the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask Work of breathing will be estimated with the pressure-time product PTP of the pleural pressure
A pneumotachograph KleisTek will record flow airway pressure Pes and Pga on a dedicated laptop
At the end of each cycle the patient will be asked to rate hisher discomfort on a visual analog scale VAS modified for ICU patients The level of dyspnea will be assessed with the Borg dyspnea scale
The following parameters will be record at the end of each cycle
Arterial pressure heart rate respiratory rate SpO2 pH PCO2 PaO2 SaO2 Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies ineffective efforts double cycling premature cycling delayed cycling and asynchrony index number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles triggered or not and of wasted efforts will be computed The trigger delay will be also measured The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 inspiratory and expiratory as suggested by Ferrone and coworkers The work of breathing WOB for each breath will be estimated by PTPes
An hygrometer Dimar SRL Italy will measure and record on a dedicated laptop Helmet temperature relative and absolute humidity
Primary endpoints patients comfort work of breathing and asynchrony index
Sample Sizing
Given the physiological design of the study the investigators did not make an a priori sample size and plan to enroll 24 patients
During NIV humidification strategies heat and moisture exchangers HME or heated humidifiers HH may significantly affect patients comfort and work of breathing
Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome
However the higher dead space ie 18 Lmin and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting
The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure in terms of comfort work of breathing and patient-ventilator interaction
Methods All awake collaborative hypoxemic patients requiring mechanical ventilation will be considered for the enrollment Hypercapnic patients iePaCO245 mmHg will be excluded
Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order Each period will last 60 minutes
Passive humidification double tube circuit
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 33C
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 37C
Passive humidification with HME Y-piece circuit
Ventilatory settings Draeger Evita xl or Evita infinity ventilators
Pressure support ventilation pressure support20 cmH20 FiO2 titrated to obtain SpO2 between 92 and 98 positive end-expiratory pressure10 cmH2O maximum inspiratory time 09 seconds inspiratory flow trigger 2 lmin expiratory trigger 30 of the maximum inspiratory flow pressurization time000 s
Such settings will be kept unchanged during the whole study period An oesophageal catheter will be placed and secured to measure oesophageal pressure Pes and gastric pressure Pga Nutrivent Italy the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask Work of breathing will be estimated with the pressure-time product PTP of the pleural pressure
A pneumotachograph KleisTek will record flow airway pressure Pes and Pga on a dedicated laptop
At the end of each cycle the patient will be asked to rate hisher discomfort on a visual analog scale VAS modified for ICU patients The level of dyspnea will be assessed with the Borg dyspnea scale
The following parameters will be record at the end of each cycle
Arterial pressure heart rate respiratory rate SpO2 pH PCO2 PaO2 SaO2 Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies ineffective efforts double cycling premature cycling delayed cycling and asynchrony index number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles triggered or not and of wasted efforts will be computed The trigger delay will be also measured The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 inspiratory and expiratory as suggested by Ferrone and coworkers The work of breathing WOB for each breath will be estimated by PTPes
An hygrometer Dimar SRL Italy will measure and record on a dedicated laptop Helmet temperature relative and absolute humidity
Primary endpoints patients comfort work of breathing and asynchrony index
Sample Sizing
Given the physiological design of the study the investigators did not make an a priori sample size and plan to enroll 24 patients
Detailed Description:
Background Non invasive positive pressure ventilation NIV is among first line treatments of acute respiratory failure In patients with new-onset respiratory failure NIV was showed to reduce the rate of complications and the length of ICU stay as compared to invasive mechanical ventilation1 Several interfaces are available for non-invasive ventilation full face masks oronasal masks nasal prongs and helmets2
Despite full face and oronasal masks are more frequently used some evidence suggests that helmets may optimize patients comfort and NIV tolerability The helmet allows patients interaction speech feeding and does not limit cough In addition skin necrosis gastric distension or eye irritation are seldom observed during helmet NIV while may be consequences of long-term treatments with face masks 3 On the contrary helmet NIV hampers tidal volume monitoring is contraindicated in hypercapnic patients and requires specific ventilator settings4 Lastly when compared to face masks helmets may increase the work of breathing and worsen patient-ventilator interaction567
During NIV humidification strategies heat and moisture exchangers HME or heated humidifiers HH may significantly affect patients comfort and work of breathing 89
Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks89 no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome10
However the higher dead space ie 18 Lmin and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting
One only study assessed the effects of a HH during helmet low-flow continuous positive airway pressure on comfort in healthy volunteers11 Indeed patients suffering from acute respiratory failure may behave differently especially in terms of minute ventilation and maximum inspiratory flow
A recent bench study identified a better patient-ventilator interaction when helmet NIV was provided through a double tube circuit as compared to the Y-piece system 12 The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure in terms of comfort work of breathing and patient-ventilator interaction
Methods Design monocentric randomized cross-over trial Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order Each period will last 60 minutes
Passive humidification double tube circuit
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 33C
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 37C
Passive humidification with HME Y-piece circuit
Ventilatory settings Draeger Evita xl or Evita infinity ventilators
Pressure support ventilation pressure support20 cmH204 FiO2 titrated to obtain SpO2 between 92 and 98 positive end-expiratory pressure10 cmH2O4 maximum inspiratory time 09 seconds inspiratory flow trigger 2 lmin expiratory trigger 30 of the maximum inspiratory flow pressurization time000 s
Such settings will be kept unchanged during the whole study period An oesophageal catheter will be placed and secured to measure oesophageal pressure Pes and gastric pressure Pga Nutrivent Italy the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask13 Work of breathing will be estimated with the pressure-time product PTP of the pleural pressure13
A pneumotachograph KleisTek will record flow airway pressure Pes and Pga on a dedicated laptop
At the end of each cycle the patient will be asked to rate hisher discomfort on a visual analog scale VAS modified for ICU patients The level of dyspnea will be assessed with the Borg dyspnea scale14
The following parameters will be record at the end of each cycle
Arterial pressure heart rate respiratory rate SpO2 pH PCO2 PaO2 SaO2 Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies ineffective efforts double cycling premature cycling delayed cycling and asynchrony index number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles triggered or not and of wasted efforts will be computed15 The trigger delay will be also measured The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 inspiratory and expiratory as suggested by Ferrone and coworkers12 The work of breathing WOB for each breath will be estimated by PTPes
An hygrometer Dimar SRL Italy will measure and record on a dedicated laptop Helmet temperature relative and absolute humidity
End point
Primary endpoints patients comfort work of breathing and asynchrony index
Sample Sizing
Given the physiological design of the study the investigators did not make an a priori sample size and planned to enroll 24 patients
Statistical analysis Qualitative data will be expressed as number of events and continuous data as mean standard deviation or median Interquartile range Comparisons concerning qualitative variables will be performed with the Mc-Namar test Ordinal qualitative variables or non normal quantitative variables will be compared with the Friedmans Test the wilcoxon sum of ranks test or the Mann-Whitney test as appropriate All analysis will be performed applying a bilateral hypothesis P 005 will be considered significant Statistical analysis will be performed with SPSS 200
Despite full face and oronasal masks are more frequently used some evidence suggests that helmets may optimize patients comfort and NIV tolerability The helmet allows patients interaction speech feeding and does not limit cough In addition skin necrosis gastric distension or eye irritation are seldom observed during helmet NIV while may be consequences of long-term treatments with face masks 3 On the contrary helmet NIV hampers tidal volume monitoring is contraindicated in hypercapnic patients and requires specific ventilator settings4 Lastly when compared to face masks helmets may increase the work of breathing and worsen patient-ventilator interaction567
During NIV humidification strategies heat and moisture exchangers HME or heated humidifiers HH may significantly affect patients comfort and work of breathing 89
Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks89 no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome10
However the higher dead space ie 18 Lmin and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting
One only study assessed the effects of a HH during helmet low-flow continuous positive airway pressure on comfort in healthy volunteers11 Indeed patients suffering from acute respiratory failure may behave differently especially in terms of minute ventilation and maximum inspiratory flow
A recent bench study identified a better patient-ventilator interaction when helmet NIV was provided through a double tube circuit as compared to the Y-piece system 12 The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure in terms of comfort work of breathing and patient-ventilator interaction
Methods Design monocentric randomized cross-over trial Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order Each period will last 60 minutes
Passive humidification double tube circuit
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 33C
Heated humification MR 730 Fisher Paykel Auckland New Zealand humidification chamber temperature 37C
Passive humidification with HME Y-piece circuit
Ventilatory settings Draeger Evita xl or Evita infinity ventilators
Pressure support ventilation pressure support20 cmH204 FiO2 titrated to obtain SpO2 between 92 and 98 positive end-expiratory pressure10 cmH2O4 maximum inspiratory time 09 seconds inspiratory flow trigger 2 lmin expiratory trigger 30 of the maximum inspiratory flow pressurization time000 s
Such settings will be kept unchanged during the whole study period An oesophageal catheter will be placed and secured to measure oesophageal pressure Pes and gastric pressure Pga Nutrivent Italy the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask13 Work of breathing will be estimated with the pressure-time product PTP of the pleural pressure13
A pneumotachograph KleisTek will record flow airway pressure Pes and Pga on a dedicated laptop
At the end of each cycle the patient will be asked to rate hisher discomfort on a visual analog scale VAS modified for ICU patients The level of dyspnea will be assessed with the Borg dyspnea scale14
The following parameters will be record at the end of each cycle
Arterial pressure heart rate respiratory rate SpO2 pH PCO2 PaO2 SaO2 Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies ineffective efforts double cycling premature cycling delayed cycling and asynchrony index number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles triggered or not and of wasted efforts will be computed15 The trigger delay will be also measured The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 inspiratory and expiratory as suggested by Ferrone and coworkers12 The work of breathing WOB for each breath will be estimated by PTPes
An hygrometer Dimar SRL Italy will measure and record on a dedicated laptop Helmet temperature relative and absolute humidity
End point
Primary endpoints patients comfort work of breathing and asynchrony index
Sample Sizing
Given the physiological design of the study the investigators did not make an a priori sample size and planned to enroll 24 patients
Statistical analysis Qualitative data will be expressed as number of events and continuous data as mean standard deviation or median Interquartile range Comparisons concerning qualitative variables will be performed with the Mc-Namar test Ordinal qualitative variables or non normal quantitative variables will be compared with the Friedmans Test the wilcoxon sum of ranks test or the Mann-Whitney test as appropriate All analysis will be performed applying a bilateral hypothesis P 005 will be considered significant Statistical analysis will be performed with SPSS 200
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None