Respiratory Failure Clinical Trial
Official title:
Driving Pressure And Limitation of Expiratory Flow: Evaluation of Postoperative Pulmonary Complications in Elective Adult Cardiac Surgery.
Verified date | May 2017 |
Source | Ospedale San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is
lower than the minimum volume required to maintain the opening of the airways, there is a
derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow
limitation (EFL).
The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the
Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.
The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so
it's necessary a study to assess both. The primary end-point of the study is to evaluate the
correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the
study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay,
the rehospitalization and mortality.
It will be a prospective, observational, non-pharmacological study. It will enroll 200
patients undergoing elective adult cardiac surgery.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 years old - Ability to provide an informed consent - Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation - patients scheduled for adult elective cardiac surgery, performed with CPB and aortic cross-clamping. Exclusion Criteria: - Patient refusal to provide informed consent - Emergency surgery - Cardiac surgery with TAVI/MitraClip - Planned thoracotomy with one lung ventilation - Patients with chronic kidney insufficiency (defined as dialysis) - Patients already intubated in the peri-operative period - Patients with pneumonia in the pre-operative period (30 days before surgery) |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Raffaele | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Raffaele |
Italy,
Grieco DL, Chen L, Dres M, Brochard L. Should we use driving pressure to set tidal volume? Curr Opin Crit Care. 2017 Feb;23(1):38-44. doi: 10.1097/MCC.0000000000000377. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expiratory Flow Limitation | Through study completion, an average of 24 hours after surgery | ||
Primary | Incidence of Driving Pressure | Through study completion, an average of 24 hours after surgery | ||
Secondary | Postoperative pulmonary complication | Respiratory Failure, Pneumothorax, Atelectasis, Respiratory Infection, Bronchospasm, Pleural Effusion | Through study completion, an average of 7 days after surgery | |
Secondary | ICU length of stay | Through study completion, an average of 24 hours after surgery | ||
Secondary | Hospital length of stay | Through study completion, an average of 7 days after surgery | ||
Secondary | Duration of mechanical ventilation | Through study completion, an average of 7 days after surgery | ||
Secondary | PaO2/ FiO2 | Through study completion, an average of 24 hours after surgery | ||
Secondary | Mortality | Through study completion, an average of 7 days after surgery |
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