CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
remote ischemic preconditioning (RIPC)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02734654
NCT02734654N/ACompleted

Pulmonary Remote Preconditioning by Ischemia-reperfusion in Lung Lobectomy. A Study on the Prevention of Oxidative Stress

Instituto de Salud Carlos III·interventional·Posted Apr 12, 2016·Updated Mar 3, 2017

In Brief

A clinical study evaluating remote ischemic preconditioning (RIPC) for Acute Lung Injury. Completed, enrolled 53 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2016
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago

Interventions

remote ischemic preconditioning (RIPC)procedure

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.