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CO2 Field Saturating Alternative Techniques Comparison

NCT03961425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-07-27

No results posted yet for this study

Summary

Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up

Conditions

  • Embolism Air Post-Procedural

Interventions

BEHAVIORAL

NO CO2

Traditional mechanical Deairing

DEVICE

CO2 Cannula

NON specific, low cost delivery system

DEVICE

CO2 Cardia

Specific Commercial CO2 Diffuser

Sponsors & Collaborators

  • Cardiochirurgia E.H.

    lead OTHER

Principal Investigators

  • Luca Weltert, MD · European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-07-01
Completion
2021-07-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961425 on ClinicalTrials.gov