Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
NCT Number: NCT06491017
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mucus Retention|Mechanical Ventilation Complication
Interventions: DEVICE: MI-E Intervention protocol|DEVICE: Standard MI-E setting
Sponsor: Hospital Clinic of Barcelona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12

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.

Primary Outcome Measures: Wet volume of sputum, 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., Immediately after each intervention
Secondary Outcome Measures: Respiratory parameters: Inspiratory flow (PIF), 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), 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|Respiratory parameters: Peak expiratory flow (PEF), 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), 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|Respiratory parameters: difference between PEF-PIF;, 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), 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|Respiratory parameters: PEF:PIF ratio, 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), 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|Pulmonary mechanics parameters: Static Compliance (Cst), 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), 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.|Pulmonary mechanics parameters: Airway resistance (Raw), 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), 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.|Hemodynamics values: Heart rate, Hemodynamics parameters will be recorder from the patient's monitor., Before, immediately after MI-E interventions and after endotracheal suctioning.|Hemodynamics values: Mean arterial pressure, Hemodynamics parameters will be recorded from the patient's monitor., Before, immediately after MI-E interventions and after endotracheal suctioning.|Gas exchange: Arterial blood gas analysis, Parameters will be recorded from the patient's monitor arterial blood gas analysis., Before, immediately after endotracheal suctioning and 1 hour after interventions.|Gas exchange: Pulseoximeter oxygen saturation (SpO2), Parameters will be recorded from patient's pulseoximetry., Before, immediately after endotracheal suctioning and 1 hour after interventions.|Adverse events, 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., During the intervention/procedure and immediately after the intervention/procedure.|Numbers of participants with adverse events, Relationship between the participants who have reported adverse effects and the number of adverse effects in the study., During the intervention/procedure and immediately after the intervention/procedure.
Other Outcome Measures: Demographic variables: Age, Age will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion|Demographic variables: Gender, Gender will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.|Demographic variables: Weight, Weight (kilograms) will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.|Demographic variables: BMI, BMI (kg/m\^2) will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.|Demographic variables: Height, Height (meters) will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.|Demographic variables: Days of intubation, Days of intubation will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.|Demographic variables: Reason for ICU admission, Reason for ICU admission will be collected from the medical record. Age, gender, weight, BMI, height, days of intubation and reason for ICU admission will be collected from the medical record at patient's inclusion., Through study completion, an average of 2 years.