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VentilO Prospective Study

Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06826794
Acronym
VentilO
Enrollment
76
Registered
2025-02-14
Start date
2025-04-24
Completion date
2027-06-30
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Respiratory Acidosis

Brief summary

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.

Interventions

OTHERClinicians

Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.

DEVICEVenitlO

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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory acidosis20 minutes after initiation of mechanical ventilationThe frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH \< 7.35 and PaCO2 \> 45mmHg)

Secondary

MeasureTime frameDescription
Acid-base disorders on arrival in intensive care5 minutes after initiation of mechanical ventilationThe frequency and severity of acid-base disorders on arrival in intensive care (pH\<7.35 or pH \> 7.45)

Other

MeasureTime frameDescription
MortalityUp to intensive care unit dischargeIntensive care unit mortality
Intensive care unit lenght of stayUp to 28 days - intensive care unit length of stay - intensive care admission to intensive care dischargeIntensive care unit lenght of stay
Number of participants with an acute kidney injuryUp to 28 days - intensive care unit length of stay - intensive care admission to intensive care dischargeAcute kidney injury define by \> 27 mmol for 48 hours or 1.5 x basline value (pre surgery)
Number of participants with a barotraumaUp to extubationPresence of pneumothorax
Number of participants with hemodynamic shock - hypotensionUp to extubationRequiring \>1L of volume repletion and/or use of amines at \>0.05 mcg/kg/min or norepinephrine equivalent

Countries

Canada

Contacts

Primary ContactFrancois Lellouche Principal investigator, MD, PhD
francois.lellouche@criucpq.ulaval.ca1-418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026