Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Perioperative Complication
• Intervention / Treatment: Procedure: lung recruitment; Procedure: Standard ventilatory management

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuji Fujino, MD., Ph.D.; Phone Number: +81-6-6879-5820; Email: fujino@anes.med.osaka-u.ac.jp

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Recruiting
      • Department of Anesthesiology and Intensive Care Medicine, Osaka University
      • Contact: Yuji Fujino, MD., Ph.D.; Phone Number: +81-6-6879-5820; Email: fujino@anes.med.osaka-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lung recruitment; Standard ventilatory management with lung recruitment every 30 minutes	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.; Procedure: 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)
ACTIVE_COMPARATOR: control; Standard ventilatory management	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Toho University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2021
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopic surgery; lung recruitment; perioperative pulmonary complications
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: Reclap study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No