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

Respiratory Distress Syndrome Clinical Trial

— intellivent  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489085
• Other study ID #: S1FRTOU-3
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: July 21, 2014
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: November 2010
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (1)

Arnal JM, Wysocki M, Nafati C, Donati S, Granier I, Corno G, Durand-Gasselin J. Automatic selection of breathing pattern using adaptive support ventilation. Intensive Care Med. 2008 Jan;34(1):75-81. Epub 2007 Sep 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation , gaseous interchange and ventilation parameters	Record oxygenation , gaseous interchange and ventilation parameters	Participants are followed until they no longer need ventilation up to 10 days	No