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In-line Mechanical Insufflation-Exsufflation in the Management of Ventilated Patients

NCT05365620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-12

No results posted yet for this study

Summary

Catheter suction (CS), the standard method for airway secretion management during mechanical ventilation, is invasive and has significant hemodynamic and traumatic side effects. In-line mechanical insufflation-exsufflation (IL-MIE) is a new, noninvasive technology that clears secretions by cough-simulation, without interrupting ongoing ventilation. It is not known whether IL-MIE can be safely and effectively used as an alternative to CS in ventilated patients. Methods: A randomized, controlled, non-inferiority study comparing a standard protocol of CS, with automatic IL-MIE (CoughSync, Ruxin Medical Systems, Beijing) performed every 30 minutes, with CS added only if needed, in post-operative ventilated patients.

Conditions

  • Ventilation Therapy; Complications
  • Airway Clearance Impairment

Interventions

DEVICE

Mechanical In-Line Inexsufflation

In-line mechanical inexsufflation (IL-MIE) is a new method for performing MIE in intubated patients, which overcomes the drawbacks of MIE for ICU use . IL-MIE devices are integrated in-line with the patient's ventilator circuit, and do not themselves perform insufflations. Rather, the regular inspiration provided by the ventilator serves as the insufflation phase of each simulated cough, and the IL-MIE device performs only exsufflation, timing the onset of each exsufflation to the beginning of passive exhalation. Figure 1 demonstrates the setup and mode of operation of an IL-MIE device. The concept of IL-MIE was first developed by one of the authors (EB) in the Department of Respiratory Rehabilitation of ALYN Hospital in Jerusalem, Israel.

PROCEDURE

catheter suction

catheter suction is the standard, routine method for clearing secretions from the airway of a ventilated subject, by means of inserting a catheter into the endotracheal tube.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Alyn Pediatric & Adolescent Rehabilitation Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2018-07-01
Completion
2018-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365620 on ClinicalTrials.gov