Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress Syndrome

Rational: Intellivent is a ventilation mode completely automated which controls ventilation and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated in post operative heart surgery for patient with a controlled ventilation on short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit patients from intubation to coming off.

Primary objective : Compare parameters which have been selected by automated mod (Intellivent) to those selected by clinical practitioner in a conventional mode

Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters. Record complications, number of manual adjustments and prognostic signs.

Methodology: Patients in the intensive care unit who need invasive ventilation. They will be included after a detailed information (information note). Oxygenation and ventilation parameters will be recorded 2 times by day from intubation to coming off. The investigator in charge will determine daily at the bedside of the patient the adjustments he should make in a conventional mode. These adjustments will be compared to the IntelliVent automated adjustments.

Experimental study, observational, prospective, comparative, opened, monocentric in an intensive care unit.

Number of patients: 100

Completed

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Toulon, 83056, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient which needs an invasive ventilation
Intubation < 24 hours
Age ≥ 18 years

Exclusion criteria

Patient which has withdrawal standard in line with the unit coming off procedure (all criteria must be present)
temperature ≤ 38,5°C
No pressor drug
No sedation,
Motor response to order,
Cough during bronchoaspiration
%VM ≤ 130%, FiO2 ≤ 50%, PEEP ≤ 5 cmH2O, Pinsp ≤ 25 cmH2O.
Patient with non invasive ventilation .
Dysfunctions of the ventilatory command (ex Cheyne-Stokes).
Broncho pleural fistula.
Brain dead status.
Pregnant woman.
Adult under guardianship.
Person deprived of liberty

Treatment and study plan

Primary outcomes

oxygenation , gaseous interchange and ventilation parameters

Time frame: Participants are followed until they no longer need ventilation up to 10 days

Record oxygenation , gaseous interchange and ventilation parameters

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

Etude Clinique Observationnelle, Prospective, Ouverte, Monocentrique Sur l'Utilisation d'un Mode Ventilatoire entièrement automatisé Chez Les Patients de réanimation de l'Intubation Jusqu'au Sevrage.

Acronym: intellivent

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Dec 9, 2011
Registry last updated: Jul 22, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed