Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation

NCT06491017 | Not Yet Recruiting

• 1 other identifier: HCB/2023/1101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucus Retention; Mechanical Ventilation Complication

Keywords

Mechanical insufflation-exsufflation; Physiotherapy; Mucus retention; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

• 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

• 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

• 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.

Other Outcomes (7)

• Demographic variables: Age

  Through study completion

• Demographic variables: Gender

  Through study completion, an average of 2 years.

• Demographic variables: Weight

  Through study completion, an average of 2 years.

Study Arms (2)

MI-E intervention protocol

EXPERIMENTAL

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

Device: MI-E Intervention protocol

Standard MI-E setting

ACTIVE COMPARATOR

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

Device: Standard MI-E setting

Interventions

MI-E Intervention protocol DEVICE

The endotracheal tube cuff will be inflated to 40 cmH2O and MI-E device will be used to deliver MI-E in automatic mode, with 4 sets of 5 respiratory cycles each and a 1-minute interval between each set. Before initiation of the MI-E intervention protocol, the investigators will carry out a short-period test to find the appropriate MI-E settings to achieve inspiratory volumes of ≥1 liter and PEF ≥80 L/min. Concretely, inspiratory and expiratory time will always be set at 4 seconds and 2 seconds, respectively, and inspiratory flow will always be in slow mode. Once the appropriate inspiratory pressure will be found, the expiratory pressure will be initially set to exceed in 30 cmH2O the inspiratory pressure and, if required, this will be increased by 5 cmH2O until achieving a PEF ≥80 L/min with a maximum expiratory pressure of 70 cmH2O.

MI-E intervention protocol

Standard MI-E setting DEVICE

Cough Assist E70 device (Philips Respironics, USA, Andover, Massachusetts) will be used to deliver MI-E in automatic mode, with 4 sets of 5 respiratory cycles each and a 1-minute interval between each set. During the 1-minute pause between sets, the patient will be reconnected to the ventilator to avoid desaturation and de-recruitment during procedures. PEEP will remain stable during the protocol. 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.

Standard MI-E setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (23)

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Study Officials

• Joan Daniel Martí, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dani M Romeu, PhD

CONTACT

93-2275400; jd.martibcn@gmail.com

Gonzalo Basllesteros Reviriego, Msc

CONTACT

0034659129059; ballestero15@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: July 8, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)