NCT01695603CompletedNot Applicable
Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
Prof. Philippe Jolliet2 sites in 1 country23 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Partial pressure of carbon dioxide
Study Overview
Brief Summary
Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
- •Glasgow coma scale of 9 or less
- •Controlled mechanical ventilation required
- •Intracranial pressure monitoring required for clinical reasons
Exclusion Criteria
- •age under 16 years old
- •clinical signs of brainstem lesions
- •patients with withdrawal order or for whom organ donation is under discussion
- •major haemodynamic instability
- •High carbon dioxide alveoloarterial gradient (>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 < 150 mmHg)
- •Patients included in another interventional clinical study
Outcomes
Primary Outcomes
Partial pressure of carbon dioxide
The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Secondary Outcomes
- Number of settings modifications
- Partial pressure of oxygen
- Number of alarms generated by the ventilator
- Cerebral perfusion pressure
- Intracranial pressure
- Respiratory parameters
- Cerebral vasoreactivity
- Partial pressure of oxygen in the brain tissue if available
- Number of therapeutic actions needed to reduce intracranial pressure
Investigators
Prof. Philippe Jolliet
Main investigator
University of Lausanne Hospitals
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of BronchiolitisBronchiolitisNCT06053684Montefiore Medical Center130
Completed
Not Applicable
Performance of Neurally Adjusted Ventilatory Assist (NAVA) During Spontaneous Breathing TrialRespiratory FailureNCT01337271University of Sao Paulo General Hospital20
Withdrawn
Phase 4
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU PatientsMechanical VentilationWeaningNCT00813839University of California, San Francisco
Completed
Not Applicable
Adaptive Non-invasive Ventilation to Abolish Tidal Flow LimitationPulmonary Disease, Chronic ObstructiveVentilator LungHypercapniaNCT04497090Politecnico di Milano12
Completed
Not Applicable
Observational Study Evaluating the Use of Intellivent® for Patients With Respiratory Distress SyndromeRespiratory Distress SyndromeNCT01489085Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer100