Back to resultsEffect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Lung Neoplasms focused on measuring remote ischemic preconditioning, lung injury, pulmonary resection
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of pulmonary carcinoma
- Must be received pulmonary lobectomy
Exclusion Criteria:
- Cardiac disease categorized as NYHA classes II-IV
- Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted),
- Pre-existing coagulopathy or thrombocytopenia
- Prior receipt of chemotherapy or radiation therapy or immunotherapy
- Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃)
- Peripheral vascular disease affecting the upper limbs
- Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.
Sites / Locations
- Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
preconditioning
conventional
Arm Description
Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.
Outcomes
Primary Outcome Measures
Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy
PaO2/FiO2 in the limb RIPC group was significantly higher than that in the control group at 30 and 60 min after OLV, 30 min and 6 h after operation (all P<0.05)
Secondary Outcome Measures
Cs and Cd
Cs and Cd in limb RIPC group were significantly higher than those in the control group at 30 and 60 min after OLV (all P<0.05)
IL-6 and TNF-α
The IL-6 levels in the limb RIPC group were lower than those in the control group at 30 min, 6, 12, 24 and 48 h after operation (all P<0.05), and there was a significant difference in TNF-α level between the groups (P<0.01).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01307085
Brief Title
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
Official Title
Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cai Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.
Detailed Description
Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
remote ischemic preconditioning, lung injury, pulmonary resection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preconditioning
Arm Type
Experimental
Arm Description
Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
Arm Title
conventional
Arm Type
No Intervention
Arm Description
Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning
Other Intervention Name(s)
RIP
Intervention Description
Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Primary Outcome Measure Information:
Title
Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy
Description
PaO2/FiO2 in the limb RIPC group was significantly higher than that in the control group at 30 and 60 min after OLV, 30 min and 6 h after operation (all P<0.05)
Time Frame
June,2013
Secondary Outcome Measure Information:
Title
Cs and Cd
Description
Cs and Cd in limb RIPC group were significantly higher than those in the control group at 30 and 60 min after OLV (all P<0.05)
Time Frame
June,2013
Title
IL-6 and TNF-α
Description
The IL-6 levels in the limb RIPC group were lower than those in the control group at 30 min, 6, 12, 24 and 48 h after operation (all P<0.05), and there was a significant difference in TNF-α level between the groups (P<0.01).
Time Frame
June,2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of pulmonary carcinoma
Must be received pulmonary lobectomy
Exclusion Criteria:
Cardiac disease categorized as NYHA classes II-IV
Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted),
Pre-existing coagulopathy or thrombocytopenia
Prior receipt of chemotherapy or radiation therapy or immunotherapy
Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃)
Peripheral vascular disease affecting the upper limbs
Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan Ke Liu, Ph.d
Organizational Affiliation
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
We'll reach out to this number within 24 hrs