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The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question[s] it aims to answer are:
Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:
Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFL Positive - intervention | Experimental | Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be therefore set according to this value. |
|
| EFL Positive - control group | Active Comparator | Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be set at a fixed level of 4 cmH2O. |
|
| EFL negative patients | No Intervention | Patients with negative positive end-expiratory pressure test (no expiratory flow limitation) will be treated according to the current evidence and followed up for 7 days after surgery to evaluate the incidence of pulmonary postoperative complications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation | Procedure | Positive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complications | The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery | First 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Oxygenation | The investigators will evaluate postoperative oxygenation after surgery | Within 2 hours after surgery |
| Need for intubation or non-invasive ventilation | The investigators will evaluate the need for intubation or non-invasive ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Savino Spadaro, PhD | Contact | 0532/235605 | savino.spadaro@unife.it |
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| Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation | Procedure | Positive End expiratory pressure will be set not according to the positive end-expiratory pressure able to revert the expiratory flow limitation but to a standard level of 4 cmH2O. |
|
| First 7 days after surgery |
| Days of hospitalization | The investigators will evaluate the number of days of hospital stay | From hospital entrance to hospital discharge, assessed up to 30 days |
| Need for Intensive Care admission | The investigators will evaluate the need for Intensive Care admission | From hospital entrance to hospital discharge, assessed up to 30 days |
| Length of stay in ICU | The investigators will evaluate the length of Intensive care unit stay | From intensive care entrance to intensive care discharge, assessed up to 30 days |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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