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Alveolar Recruitment Maneuver During Pneumoperitoneum

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ClinicalTrials.gov Identifier: NCT03331471
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center

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.

Condition or disease Intervention/treatment Phase
Oxygen Deficiency Procedure: alveolar recruitment maneuver Procedure: conventional ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

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 Name: 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 Name: conventional




Primary Outcome Measures :
  1. lung complications [ Time Frame: 2 days after laparoscopic surgery ]
    Incidence of lung complications



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331471


Locations
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Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
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Study Chair: Kyung Cheon Lee Gachon University Gil Medical Center
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Responsible Party: Youn Yi Jo, associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT03331471    
Other Study ID Numbers: 2017-270
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not yet decided

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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
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory