Asynchronies in NIV With External Gas

Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study

NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.

Study Overview

• Status: Completed
• Conditions: Non-invasive Ventilation
• Intervention / Treatment: Device: external gas during NIV

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Cristina Lalmolda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before)

Description

Inclusion Criteria:

• over 18 years of age,
• hospital admission for acute chronic respiratory failure,
• home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).

Exclusion Criteria:

• Patients with underlying psychiatric disease were excluded

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

one group; patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before)

Device: external gas during NIV; The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchronies ( yes or no)	Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV	1 day
Type of asynchronies	autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of asynchronies pre	autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment	1 day
Type of asynchronies post	autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV	1 day
Asynchronies ( yes or no) pre	Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV	1 day
Asynchronies ( yes or no) post	Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV	1 day

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Cristina Lalmolda, RT PhD, Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Non-invasive Ventilation; trigger asynchronies; autotriggering; bench study
• Other Study ID Numbers: gasNIV