Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

Hypoxia Clinical Trial

Official title:

Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728945
• Other study ID #: Reclap study
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Osaka University
• Contact: Yuji Fujino, MD., Ph.D.
• Phone: +81-6-6879-5820
• Email: fujino[@]anes.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Perioperative Complication

Intervention

Procedure:
• lung recruitment
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
• Standard 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)

Locations

Country	Name	City	State
Japan	Department of Anesthesiology and Intensive Care Medicine, Osaka University	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Toho University School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoxia	SpO2 less than 95% or more than 2% decrease from baseline	During laparoscopy procedure
Primary	Time to onset of hypoxia	Duration from the start of laparoscopic surgery to the onset of hypoxia	During laparoscopy procedure
Secondary	Rate of decrease in SpO2	Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery	During laparoscopy procedure
Secondary	Ventilator setting at the end of surgery	Ventilator settings such as FIO2, PEEP, and plateau pressure	During surgery
Secondary	compliance rate of lung recruitment	compliance rate of lung recruitment in the intevention group	During laparoscopy procedure
Secondary	Safety endpoint: Circulatory agonist use	Circulatory agonist use	During surgery
Secondary	Safety endpoint: total fluid infusion	total fluid infusion	During surgery
Secondary	Safety endpoint: incidence of complications	incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)	During surgery
Secondary	Postoperative hypoxia	Presence of hypoxia the day after surgery	the day after surgery