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Effect of different ventilation strategies on patient outcomes post-cardiopulmonary bypass

Effect of different ventilation strategies on the proportion of patients requiring non-invasive ventilation post-cardiopulmonary bypass

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000133932
Acronym
None
Enrollment
200
Registered
2020-02-11
Start date
2020-04-06
Completion date
2021-02-28
Last updated
2020-02-17

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

Conditions

None listed

Brief summary

We aim to ascertain if there is a correlation between differing ventilation techniques post-CPB and associated post-operative outcomes. We propose to deliver PEEP at pressures that are currently practised (7 cmH2O) and change tidal volumes delivered to these patients. We hypothesise that higher tidal volumes (10ml/kg IBW) with current moderate PEEP settings correlate with reduced use of Continuous Positive Airway Pressure or Non-Invasive Ventilation (CPAP/NIV) post extubation.

Interventions

Delivered tidal volumes of 6ml/kg of ideal body weight versus 10ml/kg of ideal body weight in mechanically ventilated patients post-cardiopulmonary bypass. - Ventilation between CPB and admission to ICU will be outside of the study's remit and delivered by GE ventilator in theatre. - Mechanical ventilation for the purpose of the study will begin when the patient is admitted to ICU. Tidal volumes, as per randomisation, will be delivered until the patient is extubated or up to 90 days. - Mechanica

Delivered tidal volumes of 6ml/kg of ideal body weight versus 10ml/kg of ideal body weight in mechanically ventilated patients post-cardiopulmonary bypass. - Ventilation between CPB and admission to ICU will be outside of the study's remit and delivered by GE ventilator in theatre. - Mechanical ventilation for the purpose of the study will begin when the patient is admitted to ICU. Tidal volumes, as per randomisation, will be delivered until the patient is extubated or up to 90 days. - Mechanical ventilator used on ICU for the study: Maquet Servo-i ventilator - NIV used in ICU for the study: Maquet Servo-i ventilator - Fidelity to the intervention is assessed depending on the system operated on for the patient. 1) a linked in computerised system that slaves real-time data about ventilator settings, volumes, pressures and other vital monitoring. 2) paper notes taken by nurses on standard ICU flow charts. Both of these systems will be interrogated for each patient by the investigators to ensure study protocols were adhered to at all times

Sponsors

Prince of Wales Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

- Male or female - 18 to 85 years old

Exclusion criteria

- Any patient that did not undergo cardiopulmonary bypass - Patients undergoing a salvage operation - Pre-operative intra-aortic balloon pump - Pre-operative ECMO

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026