NCT01307085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

March 1, 2011

Last Update Submit

December 11, 2013

Conditions

Keywords

remote ischemic preconditioninglung injurypulmonary resection

Outcome Measures

Primary Outcomes (1)

  • 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)

    June,2013

Secondary Outcomes (2)

  • Cs and Cd

    June,2013

  • IL-6 and TNF-α

    June,2013

Study Arms (2)

preconditioning

EXPERIMENTAL

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

Procedure: remote ischemic preconditioning

conventional

NO INTERVENTION

Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.

Interventions

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.

Also known as: RIP
preconditioning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lung NeoplasmsLung Injury

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Xuan Ke Liu, Ph.d

    Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations