Effect of Mode of Transport Ventilation on Respiratory Parameters After Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02740075|
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : July 24, 2019
|Condition or disease|
|Complication of Ventilation Therapy|
After cardiac surgery, patients can have poor respiratory function and hemodynamics. The exact cause and contributing factors of this deterioration are not usually known and, often these patients demonstrate normal parameters at the end of surgery, but are significantly altered upon arrival in the ICU. Transportation of patients from the OR to the ICU is a period of significantly less intense monitoring and less well-controlled interventions (for example tidal volume (Vt) is largely arbitrary). Recent evidence suggests that the risk of intra-hospital transportation is significantly higher for ventilated patients than for all other patients. Some of this risk might be mitigated by the mode of ventilation because pulmonary and hemodynamic parameters are rarely measured during transportation. If the method used for ventilation and oxygenation during transport is important in maintaining stability upon presentation to the ICU, clinicians might choose one method over another. This would change clinical practice.
This is a prospective observational study assessing the effect of different modes of transport ventilation on respiratory and hemodynamic parameters on post cardiothoracic (CT) surgery patients admitted to the ICU. It is standard of care to measure peripheral blood CO2 (either end-tidal or arterial), minute volume, heart rate, blood pressure, cardiac output and pulmonary artery pressure for all patients admitted to the ICU after cardiac surgery. The investigators will simply record these values during transport and immediately on arrival in the ICU. At a 2 sided significance level of 0.05, the investigators will enroll 32 patients to detect a minimal difference from baseline ETCO2 of 15% at a power of 0.8.
The investigators will review each subjects medical record to obtain vital sign information and ventilatory parameters. The investigators will obtain individual HIPAA authorization from each subject.
All subjects will have just undergone cardiac surgery are intubated and are being transported to the ICU with either method of ventilation. The patients will be adult (age 18 and over who are competent to give their own consent). They will be recruited prior to surgery according to the inclusion and exclusion criteria listed below. No consideration will be made to gender, race, sexual orientation or national origin.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Effect of Mode of Transport Ventilation on Respiratory Parameters After Cardiac Surgery|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
This group will be transported from the operating room to the intensive care unit with the anesthesia provider ventilating the patient by hand via Mapleson circuit and supplemental oxygen. Vital signs and end-tidal carbon dioxide will be monitored and recorded by one of the investigators. The anesthesia provider will be blinded to the end-tidal carbon dioxide levels and respiratory rate.
This group will be transported from the operating room to the intensive care unit with the patient being ventilated by a transport ventilator with controlled tidal volume, respiratory rate, and positive end-expiratory pressure. Vital signs and end-tidal carbon dioxide will be monitored and recorded by one of the investigators.
- Measure the collective differences in end-tidal carbon dioxide upon arrival in the ICU between mechanical ventilation and hand-ventilation [ Time Frame: Baseline ]
- Measure the collective differences in pulmonary arterial pressures upon arrival in the ICU between mechanical ventilation and hand-ventilation [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740075
|United States, California|
|UCSD Thornton Hopsital|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Edward O'Brien, MD||University of California, San Diego|