Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Lobectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01307085
First received: March 1, 2011
Last updated: October 7, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary lobectomy.


Condition Intervention
Lung Neoplasms
Procedure: remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Lobectomy:a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy [ Time Frame: Jan,2012 ] [ Designated as safety issue: Yes ]
    Compared with the control group, patients in the LRIP group had significantly higher Cs and Cd , along with lower PA-aDO2 and RI at various phase (P<0.05). Serum concentration of IL-6,IL-8, TNF-ɑ and MDA in LRIP group were decreased significantly at postoperative time points compared with those in control group (P<0.05), but SOD was increased significantly at the same time (P<0.05).


Enrollment: 74
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preconditioning
Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
Procedure: remote ischemic preconditioning
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.
Other Name: RIP
No Intervention: conventional
Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.

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 lobectomy, 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of pulmonary carcinoma
  • Must be received pulmonary lobectomy

Exclusion Criteria:

  • Restrictive ventilatory disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307085

Locations
China, Guangdong
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Cai Li
Investigators
Principal Investigator: Xuan Ke Liu, Ph.d Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Cai Li, Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01307085     History of Changes
Other Study ID Numbers: RIP1126
Study First Received: March 1, 2011
Last Updated: October 7, 2012
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
remote ischemic preconditioning
lung injury
pulmonary lobectomy

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Lung Injury
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013