Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

NCT ID: NCT04728945

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2023-12-31

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.

Conditions

Perioperative Complication; Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

lung recruitment

Standard ventilatory management with lung recruitment every 30 minutes

Group Type: EXPERIMENTAL

lung recruitment

Intervention Type: PROCEDURE

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

Intervention Type: 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)

control

Standard ventilatory management

Group Type: ACTIVE_COMPARATOR

Standard ventilatory management

Intervention Type: 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)

Interventions

lung recruitment

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

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toho University

OTHER

Sponsor Role: collaborator

Osaka University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuji Fujino

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Locations

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Suita, Osaka, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yuji Fujino, MD., Ph.D.

Role: CONTACT

fujino@anes.med.osaka-u.ac.jp

+81-6-6879-5820

Facility Contacts

Yuji Fujino, MD., Ph.D.

Role: primary

fujino@anes.med.osaka-u.ac.jp

+81-6-6879-5820

Other Identifiers

Reclap study

Identifier Type: -

Identifier Source: org_study_id