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

NCT01489085 | Completed DMC

• 1 other identifier: S1FRTOU-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Respiratory Distress Syndrome

Keywords

ventilation; automated

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care Unit intubated Patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Toulon, 83056, France

Location

Related Publications (2)

• 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. doi: 10.1007/s00134-007-0847-0. Epub 2007 Sep 11.

  PMID: 17846747 BACKGROUND

• Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.

  PMID: 24025234 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jean-michel arnal, ph

  Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 22, 2014

Record last verified: 2010-11

Locations

FR (1)