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| Name | Class |
|---|---|
| Toho University | OTHER |
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Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lung recruitment | Experimental | Standard ventilatory management with lung recruitment every 30 minutes |
|
| control | Active Comparator | Standard ventilatory management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lung recruitment | Procedure | Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia | SpO2 less than 95% or more than 2% decrease from baseline | During laparoscopy procedure |
| Time to onset of hypoxia | Duration from the start of laparoscopic surgery to the onset of hypoxia | During laparoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decrease in SpO2 | Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery | During laparoscopy procedure |
| Ventilator setting at the end of surgery | Ventilator settings such as FIO2, PEEP, and plateau pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuji Fujino, MD., Ph.D. | Contact | +81-6-6879-5820 | fujino@anes.med.osaka-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yuji Fujino | Department of Anesthesiology and Intensive Care Medicine, Osaka University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, Osaka University | Recruiting | Suita | Osaka | 565-0871 | Japan |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard ventilatory management | Procedure | After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW) |
|
| During surgery |
| compliance rate of lung recruitment | compliance rate of lung recruitment in the intevention group | During laparoscopy procedure |
| Safety endpoint: Circulatory agonist use | Circulatory agonist use | During surgery |
| Safety endpoint: total fluid infusion | total fluid infusion | During surgery |
| Safety endpoint: incidence of complications | incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator) | During surgery |
| Postoperative hypoxia | Presence of hypoxia the day after surgery | the day after surgery |