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OpenTrials
Completed

NCT Number: NCT04884828

Asynchronies in NIV With External Gas

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.

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Key information

Conditions

Non-invasive Ventilation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cristina Lalmolda

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Asynchronies ( yes or no)

    Time frame: 1 day

    Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV

  2. Type of asynchronies

    Time frame: 1 day

    autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV

Secondary outcomes

  1. Type of asynchronies pre

    Time frame: 1 day

    autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment

  2. Type of asynchronies post

    Time frame: 1 day

    autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV

  3. Asynchronies ( yes or no) pre

    Time frame: 1 day

    Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV

  4. Asynchronies ( yes or no) post

    Time frame: 1 day

    Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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