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Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

Primary Purpose

Perioperative Complication, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
lung recruitment
Standard ventilatory management
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perioperative Complication focused on measuring perioperative pulmonary complications, lung recruitment, laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Intensive Care Medicine, Osaka UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lung recruitment

control

Arm Description

Standard ventilatory management with lung recruitment every 30 minutes

Standard ventilatory management

Outcomes

Primary Outcome Measures

Incidence of hypoxia
SpO2 less than 95% or more than 2% decrease from baseline
Time to onset of hypoxia
Duration from the start of laparoscopic surgery to the onset of hypoxia

Secondary Outcome Measures

Rate of decrease in SpO2
Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery
Ventilator setting at the end of surgery
Ventilator settings such as FIO2, PEEP, and plateau pressure
compliance rate of lung recruitment
compliance rate of lung recruitment in the intevention group
Safety endpoint: Circulatory agonist use
Circulatory agonist use
Safety endpoint: total fluid infusion
total fluid infusion
Safety endpoint: incidence of complications
incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)
Postoperative hypoxia
Presence of hypoxia the day after surgery

Full Information

First Posted
January 25, 2021
Last Updated
August 24, 2021
Sponsor
Osaka University
Collaborators
Toho University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04728945
Brief Title
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery
Official Title
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osaka University
Collaborators
Toho University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Complication, Hypoxia
Keywords
perioperative pulmonary complications, lung recruitment, laparoscopic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lung recruitment
Arm Type
Experimental
Arm Description
Standard ventilatory management with lung recruitment every 30 minutes
Arm Title
control
Arm Type
Active Comparator
Arm Description
Standard ventilatory management
Intervention Type
Procedure
Intervention Name(s)
lung recruitment
Intervention Description
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
Intervention Name(s)
Standard ventilatory management
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incidence of hypoxia
Description
SpO2 less than 95% or more than 2% decrease from baseline
Time Frame
During laparoscopy procedure
Title
Time to onset of hypoxia
Description
Duration from the start of laparoscopic surgery to the onset of hypoxia
Time Frame
During laparoscopy procedure
Secondary Outcome Measure Information:
Title
Rate of decrease in SpO2
Description
Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery
Time Frame
During laparoscopy procedure
Title
Ventilator setting at the end of surgery
Description
Ventilator settings such as FIO2, PEEP, and plateau pressure
Time Frame
During surgery
Title
compliance rate of lung recruitment
Description
compliance rate of lung recruitment in the intevention group
Time Frame
During laparoscopy procedure
Title
Safety endpoint: Circulatory agonist use
Description
Circulatory agonist use
Time Frame
During surgery
Title
Safety endpoint: total fluid infusion
Description
total fluid infusion
Time Frame
During surgery
Title
Safety endpoint: incidence of complications
Description
incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)
Time Frame
During surgery
Title
Postoperative hypoxia
Description
Presence of hypoxia the day after surgery
Time Frame
the day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuji Fujino, MD., Ph.D.
Phone
+81-6-6879-5820
Email
fujino@anes.med.osaka-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Fujino
Organizational Affiliation
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine, Osaka University
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Fujino, MD., Ph.D.
Phone
+81-6-6879-5820
Email
fujino@anes.med.osaka-u.ac.jp

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

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