Alveolar Recruitment Maneuver During Pneumoperitoneum

February 16, 2020 updated by: Youn Yi Jo, Gachon University Gil Medical Center

Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary mechanics. Especially in the eldery, decreased pulmonary function might aggravate negative response to pneumoperitoneum. Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics. Investigator designed this study for comparision of the incidences of pulmonary complications after applying alveolar recruitment maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:uncontrolled cardiovascular disease, obstructive pulmonary disorder, acute or chronic inflammatory lesion in lung.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: alveolar recruitment maneuver
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
applying alveolar recruitment maneuver using the anesthesia machine
Other Names:
  • ARM
Experimental: conventional ventilation
FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia
Procedure: conventional ventilation
conventional ventilation using the anesthesia machine
Other Names:
  • conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lung complications
Time Frame: 2 days after laparoscopic surgery
Incidence of lung complications
2 days after laparoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Chair: Kyung Cheon Lee, Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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