Hypoxia, Perioperative Complication
Conditions
Keywords
perioperative pulmonary complications, lung recruitment, laparoscopic surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElung recruitment
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
PROCEDUREStandard ventilatory management
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)
Sponsors
Toho University
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours
Exclusion criteria
* Lateral or supine position * BMI \> 35 * One-second rate \<70%, %VC \<80%, obstructive, restrictive, with bra * Cardiovascular disease (NYHA III or higher) * Intracranial hypertensive disease * Emergency surgery * Pregnancy * Glaucoma * Patients judged unsuitable by the anesthesiologist in charge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxia | During laparoscopy procedure | SpO2 less than 95% or more than 2% decrease from baseline |
| Time to onset of hypoxia | During laparoscopy procedure | Duration from the start of laparoscopic surgery to the onset of hypoxia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compliance rate of lung recruitment | During laparoscopy procedure | compliance rate of lung recruitment in the intevention group |
| Safety endpoint: Circulatory agonist use | During surgery | Circulatory agonist use |
| Rate of decrease in SpO2 | During laparoscopy procedure | Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery |
| Safety endpoint: incidence of complications | During surgery | incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator) |
| Postoperative hypoxia | the day after surgery | Presence of hypoxia the day after surgery |
| Safety endpoint: total fluid infusion | During surgery | total fluid infusion |
| Ventilator setting at the end of surgery | During surgery | Ventilator settings such as FIO2, PEEP, and plateau pressure |
Countries
Japan
Contacts
Primary ContactYuji Fujino, MD., Ph.D.
Outcome results
None listed