NCT03331471

Brief Summary

Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

November 1, 2017

Last Update Submit

February 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung complications

    Incidence of lung complications

    2 days after laparoscopic surgery

Study Arms (2)

alveolar recruitment maneuver

ACTIVE COMPARATOR

FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O and applying alveolar recruitment maneuver (PEEP 10 cmH2O for 3 breath - PEEP 15 cmH2O for 3 breath and PEEP 20 cmH2O for 10 breath) immediate before and after pneumoperitoneum

Procedure: alveolar recruitment maneuver

conventional ventilation

EXPERIMENTAL

FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia

Procedure: conventional ventilation

Interventions

applying alveolar recruitment maneuver using the anesthesia machine

Also known as: ARM
alveolar recruitment maneuver

conventional ventilation using the anesthesia machine

Also known as: conventional
conventional ventilation

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • over 65 years, patients who undergoing elective laparoscopoic colorectal surgery for cancer under general anesthesia. ASA pysical status I or II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gachon University Gil Hospital

Incheon, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Kyung Cheon Lee

    Gachon University Gil Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

September 18, 2017

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

not yet decided

Locations