Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491017
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-15
Brief Title:
Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Suctioned Wet Mucus Volume During Invasive Ventilation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation MVThis complication is often due to excessive secretion production and ineffective secretion clearance
Mechanical insufflator-exsufflator MI-E is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device A positive airway pressure is delivered to the airways in order to hyperinflate the lungs followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows
However there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients Inspiratory and expiratory pressures of 40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds respectively are often used as a standard for MI-E programming in the daily routine practice but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias
The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours
Mechanical insufflator-exsufflator MI-E is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device A positive airway pressure is delivered to the airways in order to hyperinflate the lungs followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows
However there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients Inspiratory and expiratory pressures of 40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds respectively are often used as a standard for MI-E programming in the daily routine practice but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias
The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours
Detailed Description:
Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation MV This complication is often due to excessive secretion production and ineffective secretion clearance One of the main causes is the presence of an endotracheal tube ETT which has been shown to decrease mucociliary clearance and hinders the generation of adequate peak expiratory flows when coughing Other factors such as suboptimal airway humidification inspiratory flow bias semi-recumbent position prolonged immobilization and respiratory muscles weakness further impair sputum clearance Mucus retention may impede optimal gas exchange and lead to atelectasis increased work of breathing bacterial colonization and development of pulmonary infections prolonging the need for MV These conditions added to initial factors increase morbidity and mortality in critically ill patients making secretion clearance an essential factor for patients prognosis
Secretion removal techniques such as manual or mechanical hyperinflations chest vibrations or expiratory rib cage compressions prior to suctioning are commonly used by physiotherapists in intensive care units ICU However the evidence assessing respiratory physiotherapy techniques in critically ill patients is scant and sometimes inconsistent making it difficult to extrapolate the results and standardize the clinical practice Moreover the execution of these techniques often differs among professionals based on their experience training and resources availability
Mechanical insufflator-exsufflator MI-E is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device A positive airway pressure is delivered to the airways in order to hyperinflate the lungs followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows MI-E is commonly used in patients with ineffective cough mainly due to respiratory pump failure ie neuromuscular patients and has been proposed in recent years as a technique with great potential to non-invasively clear secretions in the critically ill Indeed recent studies have evaluated safety and efficacy of MI-E in intubated critically ill patients with promising results and no associated adverse events However there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients Inspiratory and expiratory pressures of 40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds respectively are often used as a standard for MI-E programming in the daily routine practice but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias For instance Volpe et al achieved significant differences in artificial mucus displacement when inspiratory flows were lowered inspiratory time was increased to 4 seconds and expiratory flow bias was enhanced by increasing the expiratory pressure over the inspiratory pressure More recently evidence from a swine model confirmed the improvement in mucus movement velocity when expiratory pressure was enhanced to increase the difference between inspiratory and expiratory pressures ie 40-70cmH2O Importantly increased inspiratory pressures should be avoided to prevent movement of mucus toward the lungs and potential associated detrimental effects such as alveolar damage or hemodynamic impairment
The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours
Secretion removal techniques such as manual or mechanical hyperinflations chest vibrations or expiratory rib cage compressions prior to suctioning are commonly used by physiotherapists in intensive care units ICU However the evidence assessing respiratory physiotherapy techniques in critically ill patients is scant and sometimes inconsistent making it difficult to extrapolate the results and standardize the clinical practice Moreover the execution of these techniques often differs among professionals based on their experience training and resources availability
Mechanical insufflator-exsufflator MI-E is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device A positive airway pressure is delivered to the airways in order to hyperinflate the lungs followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows MI-E is commonly used in patients with ineffective cough mainly due to respiratory pump failure ie neuromuscular patients and has been proposed in recent years as a technique with great potential to non-invasively clear secretions in the critically ill Indeed recent studies have evaluated safety and efficacy of MI-E in intubated critically ill patients with promising results and no associated adverse events However there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients Inspiratory and expiratory pressures of 40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds respectively are often used as a standard for MI-E programming in the daily routine practice but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias For instance Volpe et al achieved significant differences in artificial mucus displacement when inspiratory flows were lowered inspiratory time was increased to 4 seconds and expiratory flow bias was enhanced by increasing the expiratory pressure over the inspiratory pressure More recently evidence from a swine model confirmed the improvement in mucus movement velocity when expiratory pressure was enhanced to increase the difference between inspiratory and expiratory pressures ie 40-70cmH2O Importantly increased inspiratory pressures should be avoided to prevent movement of mucus toward the lungs and potential associated detrimental effects such as alveolar damage or hemodynamic impairment
The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours
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