VentilO Prospective Study

ConditionsMechanical Ventilation Complication Respiratory Acidosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLaval University

About this trial

This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (> 18 years old)

Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)

Ventilation in controlled mode (Assist Control or SIMV)

Disqualifiers

Absence of anthropometric data (height and weight) of patients available in the patient file

Respiratory cycles mainly spontaneous on arrival

Patient extubated on arrival in intensive care

Trial design

Design model

Parallel

Treatments tested in this trial

Clinicians
Other intervention
Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.
VenitlO
Device
VentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: CliniciansOther 1 intervention

Group B: VentilOActive comparator 1 intervention

Trial outcomes

Primary outcomes

Respiratory acidosis

The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH \< 7.35 and PaCO2 \> 45mmHg)

Time frame

20 minutes after initiation of mechanical ventilation

Secondary outcomes

Acid-base disorders on arrival in intensive care

The frequency and severity of acid-base disorders on arrival in intensive care (pH\<7.35 or pH \> 7.45)

Time frame

5 minutes after initiation of mechanical ventilation

Other outcomes

Number of participants with hemodynamic shock - hypotension

Requiring \>1L of volume repletion and/or use of amines at \>0.05 mcg/kg/min or norepinephrine equivalent

Time frame

Up to extubation

Number of participants with a barotrauma

Presence of pneumothorax

Time frame

Up to extubation

Mortality

Intensive care unit mortality

Time frame

Up to intensive care unit discharge

Intensive care unit lenght of stay

Time frame

Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Source ClinicalTrials.gov

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