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Limb RIPC in Patients Undergoing Lung Lobectomy. Study of Oxidative Lung Damage

NCT02734654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-03-03

No results posted yet for this study

Summary

Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after resection is associated to severe oxidative lung injury. The researchers hypothesized that remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the oxygenation parameters.

Methods: We designed a single-centre, randomized, prospective and double-blind study, conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung lobectomy.

Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3 cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh) and 27 controls.

Time course of oxidative stress marker levels was simultaneously studied in exhaled breath condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming two-lung ventilation (TLV); T3, 120 min after resuming TLV.

EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.

Conditions

  • Acute Lung Injury

Interventions

PROCEDURE

remote ischemic preconditioning (RIPC)

Remote ischemic preconditioning: The limb RIPC was applied after the induction of anaesthesia and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on a thigh and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff on a thigh.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    lead OTHER_GOV

Principal Investigators

  • José García de la Asunción, MD, PhD · Instituto de Investigador Sanitaria, INCLIVA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-02-28
Completion
2012-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734654 on ClinicalTrials.gov