CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
carbon-dioxide insufflation +1 moredrug
Likely dose
Not stated in record
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Search/NCT00934596
NCT00934596N/ACompleted

CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy

Lund University·interventional·Posted Jul 8, 2009·Updated Dec 4, 2013

In Brief

A clinical study evaluating Lund de-airing technique and carbon-dioxide insufflation for Aortic Valve Disorder. Completed, enrolled 20 participants.

Detailed Summary

To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air. To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.0 years ago

Interventions

Lund de-airing techniqueprocedure

In these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. Deairing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB. When TEE will show no air in the left heart, the de-airing will be considered complete.

carbon-dioxide insufflationdrug

In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with Co2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.At the end of the cardioplegic arrest, the de-airing procedure is similar to that in the Lund de-airing group.