NCT04728945

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 18, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

January 25, 2021

Last Update Submit

August 24, 2021

Conditions

Perioperative ComplicationHypoxia

Keywords

perioperative pulmonary complicationslung recruitmentlaparoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Rate of decrease in SpO2

    During laparoscopy procedure

  • Ventilator setting at the end of surgery

    During surgery

  • compliance rate of lung recruitment

    During laparoscopy procedure

  • Safety endpoint: Circulatory agonist use

    During surgery

  • Safety endpoint: total fluid infusion

    During surgery

  • +2 more secondary outcomes

Study Arms (2)

lung recruitment

EXPERIMENTAL

Standard ventilatory management with lung recruitment every 30 minutes

Procedure: lung recruitmentProcedure: Standard ventilatory management

control

ACTIVE COMPARATOR

Standard ventilatory management

Procedure: Standard ventilatory management

Interventions

lung recruitmentPROCEDURE

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

lung recruitment
Standard ventilatory managementPROCEDURE

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)

controllung recruitment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Suita, Osaka, 565-0871, Japan

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuji Fujino

    Department of Anesthesiology and Intensive Care Medicine, Osaka University

    STUDY CHAIR

Central Study Contacts

Yuji Fujino, MD., Ph.D.

CONTACT

+81-6-6879-5820fujino@anes.med.osaka-u.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 28, 2021

Study Start

June 18, 2021

Primary Completion

February 28, 2023

Study Completion

December 31, 2023

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)