Thoracic Surgery Clinical Trial
Official title:
Individualized vs Standard PEEP in Thoracic Surgery: Effects on Respiratory Mechanics and Intra- and Postoperative Oxygenation
Verified date | September 2022 |
Source | University of Trieste |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intraoperative protective ventilation with low tidal volumes (TV), positive end-expiratory pressure (PEEP) and possibly lung recruitment maneuvers (RMs) reduces postoperative pulmonary complications. In thoracic surgery, in one-lung ventilation (OLV), the evidence is lacking. However, in this context protective ventilation with PEEP titration is related to better intraoperative oxygenation and respiratory mechanics. It is not clear whether this strategy is associated also with better postoperative oxygenation and less postoperative pulmonary complications.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 5, 2021 |
Est. primary completion date | December 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Patient's consent to the trial - Candidate to elective lung lobectomy or segmentectomy (minimally invasive thoracotomy or video-assisted thoracoscopy) - ASA class 1-3 - BMI < 30 kg/m2 Exclusion criteria: - Pregnancy - Previous pneumothorax, - Emphysematous bullae - Severe COPD - METs < 4 due to cardiac disease |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital | Trieste |
Lead Sponsor | Collaborator |
---|---|
University of Trieste |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of oxygenation | Oxygen arterial partial pressure/fraction of inspired oxygen (PaO2/FiO2) | The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of driving pressure | Driving pressure = Pplateau -PEEP | The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of plateau pressure | Airway pressure during an end-inspiratory pause | The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of static respiratory system compliance | Cstat = TV/(Pplat-PEEP) | The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of respiratory rate | Respiratory rate set on the ventilator | The parameter will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of carbon dioxide | Carbon dioxide arterial partial pressure | The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of end expiratory carbon dioxide partial pressure | Carbon dioxide end-expiratory partial pressure | The respiratory parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Change of pH | Arterial pH | The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons. | |
Secondary | Lactate | Arterial lactate | The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons. |
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