Back to resultsAlveolar Recruitment Maneuver During Pneumoperitoneum
Primary Purpose
Oxygen Deficiency
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
alveolar recruitment maneuver
conventional ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Oxygen Deficiency
Eligibility Criteria
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.
Sites / Locations
- Gachon University Gil Hospital
- Gachon University Gil Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
alveolar recruitment maneuver
conventional ventilation
Arm Description
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
FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia
Outcomes
Primary Outcome Measures
lung complications
Incidence of lung complications
Secondary Outcome Measures
Full Information
NCT ID
NCT03331471
First Posted
November 1, 2017
Last Updated
February 16, 2020
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03331471
Brief Title
Alveolar Recruitment Maneuver During Pneumoperitoneum
Official Title
Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alveolar recruitment maneuver
Arm Type
Active Comparator
Arm Description
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
Arm Title
conventional ventilation
Arm Type
Experimental
Arm Description
FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia
Intervention Type
Procedure
Intervention Name(s)
alveolar recruitment maneuver
Other Intervention Name(s)
ARM
Intervention Description
applying alveolar recruitment maneuver using the anesthesia machine
Intervention Type
Procedure
Intervention Name(s)
conventional ventilation
Other Intervention Name(s)
conventional
Intervention Description
conventional ventilation using the anesthesia machine
Primary Outcome Measure Information:
Title
lung complications
Description
Incidence of lung complications
Time Frame
2 days after laparoscopic surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not yet decided
Learn more about this trial
Alveolar Recruitment Maneuver During Pneumoperitoneum
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