Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
- Conditions
- Mucus RetentionMechanical Ventilation Complication
- Interventions
- Device: MI-E Intervention protocolDevice: Standard MI-E setting
- Registration Number
- NCT06491017
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
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.
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 (i.e: 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 (i.e: +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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 26
- Adults (> 18yo).
- Endotracheal intubation and invasive mechanical ventilation for > 48h and active humidification for > 24h.
- Richmond Agitation-Sedation Scale -3 to -5.
- Signed informed consent.
- Patients with hemodynamic instability (MAP < 60 or > 110, Heart Rate < 50 or > 130, new onset arrhythmias), respiratory instability (PEEP > 12cmH2O, SpO2 < 90% or fraction of inspired oxygen (FiO2) > 60%).
- Undrained pneumothorax/pneumomediastinum.
- Unstable intracranial pressure (ICP > 20mmHg or MAP < 60).
- Severe bronchospasm.
- Post cardiothoracic surgical patients.
- Active pulmonary tuberculosis.
- Bronchoesophageal or bronchopleural fistulas.
- Prone position.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MI-E intervention protocol MI-E Intervention protocol The optimized MI-E setting will consist of in-expiratory pressures defined during the previous short-period test to achieve inspiratory volumes of ≥1 liter and PEF ≥80 L/min Standard MI-E setting Standard MI-E setting The standard MI-E setting will consist of in-expiratory pressures of +40/-40 cmH2O, medium inspiratory flow, with 3 seconds and 2 seconds of in-expiratory time, respectively, and 1-second pause
- Primary Outcome Measures
Name Time Method Wet volume of sputum Immediately after each intervention Airway suctioning will be carried out using an open aspiration procedure, using a 12French catheter connected to a sterile collection container. The suction procedure will be performed according to international guidelines . If necessary, 5 ml of saline solution will be used to rinse the catheter in case of impacted secretions inside the catheter; later this volume will be subtracted from the final volume of secretions, thus obtaining the exact amount of wet sputum.
- Secondary Outcome Measures
Name Time Method Hemodynamics values: Heart rate Before, immediately after MI-E interventions and after endotracheal suctioning. Hemodynamics parameters will be recorder from the patient's monitor.
Hemodynamics values: Mean arterial pressure Before, immediately after MI-E interventions and after endotracheal suctioning. Hemodynamics parameters will be recorded from the patient's monitor.
Adverse events During the intervention/procedure and immediately after the intervention/procedure. All adverse events that force the interruption of the interventions will be recorded. Reasons to stop MI-E will be haemodynamic instability, severe desaturation, structural damage caused to the airway (i.e. pneumothorax), airway obstruction or difficulty in correct ventilation of the patient.
Numbers of participants with adverse events During the intervention/procedure and immediately after the intervention/procedure. Relationship between the participants who have reported adverse effects and the number of adverse effects in the study.
Gas exchange: Pulseoximeter oxygen saturation (SpO2) Before, immediately after endotracheal suctioning and 1 hour after interventions. Parameters will be recorded from patient's pulseoximetry.
Pulmonary mechanics parameters: Static Compliance (Cst) Airway pressures will be recorded before, immediately after MI-E intervention, after endotracheal suctioning, and 1h after endotracheal suctioning. Respiratory system compliance and airway resistance will be calculated using standard formulas. Pressure signals will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Pulmonary mechanics parameters: Airway resistance (Raw) Airway pressures will be recorded before, immediately after MI-E intervention, after endotracheal suctioning, and 1h after endotracheal suctioning. Respiratory system compliance and airway resistance will be calculated using standard formulas. Pressure signals will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Gas exchange: Arterial blood gas analysis Before, immediately after endotracheal suctioning and 1 hour after interventions. Parameters will be recorded from the patient's monitor arterial blood gas analysis.
Respiratory parameters: Inspiratory flow (PIF) Before and during MI-E interventions, delivered tidal volumes will be recorded, PIF and PEF will be assessed for each insufflation-exsufflation cycle, and the PEF-PIF difference and the PEF:PIF ratio will be calculated Flow will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Respiratory parameters: Peak expiratory flow (PEF) Before and during MI-E interventions, delivered tidal volumes will be recorded, PIF and PEF will be assessed for each insufflation-exsufflation cycle, and the PEF-PIF difference and the PEF:PIF ratio will be calculated Flow will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Respiratory parameters: PEF:PIF ratio Before and during MI-E interventions, delivered tidal volumes will be recorded, PIF and PEF will be assessed for each insufflation-exsufflation cycle, and the PEF-PIF difference and the PEF:PIF ratio will be calculated Flow will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Respiratory parameters: difference between PEF-PIF; Before and during MI-E interventions, delivered tidal volumes will be recorded, PIF and PEF will be assessed for each insufflation-exsufflation cycle, and the PEF-PIF difference and the PEF:PIF ratio will be calculated Flow will be measured with a heated pneumotachograph (Fluxmed GrH monitor MBMED, Buenos Aires, Argentina) inserted between the proximal tip of the endotracheal tube and the Y-piece of the breathing circuit. All signals will be recorded on a personal computer for subsequent analysis with dedicated software (FluxReview software MBMED, Buenos Aires, Argentina)
Trial Locations
- Locations (1)
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain