- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04813250
Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography
The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery
Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Neihu Dist
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Taipei City, Neihu Dist, Taiwan, 11490
- Department of Anesthesiology, Tri-Service General Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age between 20-80 year-old
- Adult patients receiving elective cardiac surgery with hypothermic CPB
Exclusion Criteria:
- Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Sham-komparator: Group R
IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Eksperimentell: Group RP
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Eksperimentell: Group RI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Eksperimentell: Group RPI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The correlation between Different ventilation mode and the relevant value of EIT
Tidsramme: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The demographic characteristics and relevant value of EIT
Tidsramme: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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If the different ventilation mode setting can improve clinical outcome
Tidsramme: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Identify the different ventilation mode setting in open heart surgery patient if can improve clinical care benifit.
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The correlation between heart function & oxygenation and different ventilation mode
Tidsramme: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Survey the correlation between heart function & oxygenation and different ventilation mode
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Ventilatory with EIT post CPB
Plan for individuelle deltakerdata (IPD)
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