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

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

Interventions

DEVICE

MI-E Intervention protocol

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.

DEVICE

Standard MI-E setting

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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Joan Daniel Martí, PhD · Hospital Clinic of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-08

Primary Completion

2026-12-31

Completion

2028-12-31

Countries

• Spain

Study Locations