Clinical trial NCT06491017: Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Official title: Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Suctioned Wet Mucus Volume During Invasive Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mucus Retention
Mechanical Ventilation Complication
Keywords: Mechanical insufflation-exsufflation
Physiotherapy
Mucus retention
mechanical ventilation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Wet volume of sputum
timeFrame: Immediately after each intervention
Secondary outcomes:
measure: Respiratory parameters: Inspiratory flow (PIF)
timeFrame: 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
measure: Respiratory parameters: Peak expiratory flow (PEF)
timeFrame: 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
measure: Respiratory parameters: difference between PEF-PIF;
timeFrame: 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
measure: Respiratory parameters: PEF:PIF ratio
timeFrame: 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
measure: Pulmonary mechanics parameters: Static Compliance (Cst)
timeFrame: 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.
measure: Pulmonary mechanics parameters: Airway resistance (Raw)
timeFrame: 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.
measure: Hemodynamics values: Heart rate
timeFrame: Before, immediately after MI-E interventions and after endotracheal suctioning.
measure: Hemodynamics values: Mean arterial pressure
timeFrame: Before, immediately after MI-E interventions and after endotracheal suctioning.
measure: Gas exchange: Arterial blood gas analysis
timeFrame: Before, immediately after endotracheal suctioning and 1 hour after interventions.
measure: Gas exchange: Pulseoximeter oxygen saturation (SpO2)
timeFrame: Before, immediately after endotracheal suctioning and 1 hour after interventions.
measure: Adverse events
timeFrame: During the intervention/procedure and immediately after the intervention/procedure.
measure: Numbers of participants with adverse events
timeFrame: During the intervention/procedure and immediately after the intervention/procedure.
Other outcomes:
measure: Demographic variables: Age
timeFrame: Through study completion
measure: Demographic variables: Gender
timeFrame: Through study completion, an average of 2 years.
measure: Demographic variables: Weight
timeFrame: Through study completion, an average of 2 years.
measure: Demographic variables: BMI
timeFrame: Through study completion, an average of 2 years.
measure: Demographic variables: Height
timeFrame: Through study completion, an average of 2 years.
measure: Demographic variables: Days of intubation
timeFrame: Through study completion, an average of 2 years.
measure: Demographic variables: Reason for ICU admission
timeFrame: Through study completion, an average of 2 years.
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Joan Daniel Martí, PhD
role: PRINCIPAL_INVESTIGATOR
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