Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

Not Applicable

Completed

• Conditions: Lung Neoplasms
• Interventions: Procedure: remote ischemic preconditioning

• Registration Number: NCT01307085
• Lead Sponsor: Cai Li

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preconditioning	remote ischemic preconditioning	Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.

Primary Outcome Measures

Name	Time	Method
Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy	June,2013	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

Name	Time	Method
Cs and Cd	June,2013	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	June,2013	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).

Trial Locations

Locations (1)

Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 GuangZhou, Guangdong, China