Asynchronies in NIV With External Gas

NCT04884828 | Completed

• 1 other identifier: gasNIV
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-invasive Ventilation

Keywords

Non-invasive Ventilation; trigger asynchronies; autotriggering; bench study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Type of asynchronies pre

  1 day

• Type of asynchronies post

  1 day

• Asynchronies ( yes or no) pre

  1 day

• Asynchronies ( yes or no) post

  1 day

Study Arms (1)

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

Interventions

external gas during NIV DEVICE

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.

one group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• Patients with underlying psychiatric disease were excluded

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Cristina Lalmolda

Sabadell, Barcelona, 08208, Spain

Location

Study Officials

• Cristina Lalmolda, RT PhD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory therapist

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 13, 2021
• Study Start: April 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 30, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

ES (1)