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- Sperimentazione clinica NCT04926649
HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery
The High-frequency Low-volume Ventilation (HFLVV) for Hypoxemia During the Weaning From Cardiopulmonary Bypass in Robot-assisted Cardiac Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Chongqing
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Chongqing, Chongqing, Cina, 400042
- Daping Hospital, Army Medical University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- scheduled for robot-assisted cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- age <18 or > 70 years
- PaO2/FiO2 ratio < 300 mmHg before anesthesia induction
- American Society of Anesthesiologist (ASA) Grade > 3
- Patients who were converted to conventional open-chest procedure
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore fittizio: Conventional ventilation group
Conventional SLV and complementary with DLV when necessary.
When SLV was initiated, the patient was ventilated with left lung.
FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O.
The right lung was totally collapsed.
If the SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%.
Then the operation was restarted.
|
When the hypoxemia occurs during sing lung ventilation in robot-assisted cardiac surgery, the non-dependent lung will be ventilated with normal tidal volume in conventional ways and the surgery procedure have to be ceased.
In this trial, the non-dependent lung will be ventilated with the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to prevent the hypoxemia.
|
Comparatore attivo: CPAP group
SLV of left lung and CPAP of right lung, and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, CPAP was started with the pressure less than 8 cmH2O. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted. |
When the hypoxemia occurs during sing lung ventilation in robot-assisted cardiac surgery, the non-dependent lung will be ventilated with normal tidal volume in conventional ways and the surgery procedure have to be ceased.
In this trial, the non-dependent lung will be ventilated with the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to prevent the hypoxemia.
|
Sperimentale: HFLVV group
SLV of left lung and HFLVV of right lung, and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, HFLVV was started with tidal volume of 2ml/kg, respiratory rate of 60 bpm. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted. |
When the hypoxemia occurs during sing lung ventilation in robot-assisted cardiac surgery, the non-dependent lung will be ventilated with normal tidal volume in conventional ways and the surgery procedure have to be ceased.
In this trial, the non-dependent lung will be ventilated with the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to prevent the hypoxemia.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes of arterial PaO2
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
Arterial PaO2 (in mmHg) defined as a measurement of partial pressure of oxygen in arterial blood
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
Changes of PaO2/FiO2 ratio
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
PaO2/FiO2 ratio defined as the ratio of PaO2 to fractional inspired oxygen (FiO2 expressed as a fraction)
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes of Heart rate
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV
|
Heart rate in beat per minute
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV
|
Changes of mean blood pressure
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
mean blood pressure in mmHg
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of cardiac stroke volume variation
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Cardiac stroke volume variation in percentages
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5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of venous pressure of jugular vein
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Venous pressure of jugular vein in cmH2O
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of tidal volume
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Tidal volume of both lungs in milliliter
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of respiratory rates
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Respiratory rates of both lungs in breath per minute
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5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of airway pressure
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Airway pressure of both lungs in mmHg
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of end-tidal carbon dioxide tension
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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End-tidal carbon dioxide tension in mmHg
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5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of blood oxygen saturation
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Blood oxygen saturation of both upper and lower extremities in percentages
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5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
Changes of the pulmonary shunt fraction
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
|
Qs/Qt = ((CcO2 - CaO2) / (CcO2 - CvO2)) * 100
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of regional cerebral oxygen saturation
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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regional cerebral oxygen saturation in percentages
|
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Changes of the surgical field
Lasso di tempo: 5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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The surgeon's evaluation of the surgical field, graded from 0 (no interference) to 3 (maximal interference)
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5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Qingxiang Mao, M.D., Ph.D., Daping Hospital, Army Medical University
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2021-59
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