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

NCT05365620 | Completed

• 1 other identifier: 047-21
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (9)

• PaO2

  Arterial partial pressure of oxygen

  change from baseline to 5 minutes

• PaO2

  Arterial partial pressure of oxygen

  change from baseline to 4 hours

• PaO2

  Arterial partial pressure of oxygen

  change from baseline to 8 hours

• SaO2

  arterial oxygen saturation

  change from baseline to 5 minutes

• SaO2

  arterial oxygen saturation

  change from baseline to 4 hours

• SaO2

  arterial oxygen saturation

  change from baseline to 8 hours

• PaO2/FiO2

  oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen

  change from baseline to 5 minutes

• PaO2/FiO2

  oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen

  change from baseline to 4 hours

• PaO2/FiO2

  oxygenation index - the ratio of blood oxygen to the percentage of inspired oxygen

  change from baseline to 8 hours

Secondary Outcomes (24)

• PaCO2

  change from baseline to 5 minutes

• PaCO2

  change from baseline to 4 hours

• PaCO2

  change from baseline to 8 hours

• SpO2

  change from baseline to 5 minutes

• SpO2

  change from baseline to 4 hours

Study Arms (2)

Catheter Suction

ACTIVE COMPARATOR

Patients in this arm were managed for 8 hours with Catheter Suction whenever the subject showed signs of airway secretion accumulation, as per standard clinical practice for those ICU's

Procedure: catheter suction

Mechanical Inexsufflation

EXPERIMENTAL

Patients in this are were managed for 8 hours with automatic inexsufflation treatments (CoughSync, Ruxin Medical Systems Company Ltd, Beijing, China) performed automatically every 30 minutes, and with Catheter Suction performed only if signs of airway secretion accumulation manifested

Device: Mechanical In-Line Inexsufflation

Interventions

Mechanical In-Line Inexsufflation DEVICE

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.

Mechanical Inexsufflation

catheter suction PROCEDURE

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.

Catheter Suction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing mechanical ventilation during the immediate recovery period following a cardiac or neuro-surgical procedure
• Ventilation expected to last more than 8 hours

You may not qualify if:

• acute spinal cord shock
• recent airway trauma or surgery
• cardiogenic pulmonary edema or ARDS necessitating ventilation with a peak end expiratory pressure (PEEP) equal to or greater than 6 cmH2O
• pneumothorax
• hemoptysis
• severe ischemic heart disease
• lung tumors
• pulmonary Tuberculosis
• history of lung transplantation
• pregnant or breastfeeding women

Sponsors & Collaborators

• Alyn Pediatric & Adolescent Rehabilitation Hospital: lead
• Beijing Anzhen Hospital: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Rehabilitation

Model Details: The study was designed as a randomized, open-label, parallel, non-inferiority, controlled trial.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: May 9, 2022
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 12, 2022

Record last verified: 2022-05