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

NCT02734654 | Completed

• 1 other identifier: PI070836
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

oxidative stress; lung lobectomy

Outcome Measures

Primary Outcomes (1)

• Time course of 8-isoprostane levels in exhaled breath condensate during and after lung lobectomy

  levels of 8-isoprostane in exhaled breath condensate were measured during lung lobectomy (T0: after anesthesia induction; T1: before two lung ventilation; T3: after two lung ventilation) and 2 hours after lobectomy in critical care unit (T3).

  Approximately 4 hours: after anesthesia (T0), during lung lobectomy (T1, T2) and 2 hours after lung lobectomy (T3)

Secondary Outcomes (1)

• Time course of PO2/FiO2 ratio in arterial blood gas during and after lung lobectomy

  during lung lobectomy (T0, T1, T2) and 24 hours after lung lobectomy in the critical care unit (T3, T4, T5)

Study Arms (2)

Control group

NO INTERVENTION

patients do not receive remote preconditioning prior to lung lobectomy

RIPC group

EXPERIMENTAL

patients receive remote preconditioning prior to lung lobectomy

Procedure: remote ischemic preconditioning (RIPC)

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.

RIPC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lung cancer patients (clinical stage I-II NSCLC)
• elective lung lobectomy
• patients were randomized and prospectively studied in a single centre
• all patients were ASA physical status I-II category
• pregnants

You may not qualify if:

• previous radiotherapy-chemotherapy
• previous thorax surgery
• PaO2 \<60 mmHg
• FEV1 \<50%
• cardiac disease (NYHA II-IV)
• active infections and temperature \>37.5 ºC

Sponsors & Collaborators

• Instituto de Salud Carlos III: lead

Related Publications (5)

• Garcia-de-la-Asuncion J, Garcia-Del-Olmo E, Galan G, Guijarro R, Marti F, Badenes R, Perez-Griera J, Duca A, Delgado C, Carbonell J, Belda J. Glutathione oxidation correlates with one-lung ventilation time and PO2/FiO2 ratio during pulmonary lobectomy. Redox Rep. 2016 Sep;21(5):219-26. doi: 10.1080/13510002.2015.1101890. Epub 2016 Jan 21.

  PMID: 26795138 BACKGROUND

• Misthos P, Katsaragakis S, Theodorou D, Milingos N, Skottis I. The degree of oxidative stress is associated with major adverse effects after lung resection: a prospective study. Eur J Cardiothorac Surg. 2006 Apr;29(4):591-5. doi: 10.1016/j.ejcts.2005.12.027. Epub 2006 Feb 14.

  PMID: 16476542 BACKGROUND

• Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.

  PMID: 16135737 BACKGROUND

• Przyklenk K, Whittaker P. Remote ischemic preconditioning: current knowledge, unresolved questions, and future priorities. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):255-9. doi: 10.1177/1074248411409040.

  PMID: 21821525 BACKGROUND

• Garcia-de-la-Asuncion J, Garcia-del-Olmo E, Perez-Griera J, Marti F, Galan G, Morcillo A, Wins R, Guijarro R, Arnau A, Sarria B, Garcia-Raimundo M, Belda J. Oxidative lung injury correlates with one-lung ventilation time during pulmonary lobectomy: a study of exhaled breath condensate and blood. Eur J Cardiothorac Surg. 2015 Sep;48(3):e37-44. doi: 10.1093/ejcts/ezv207. Epub 2015 Jun 18.

  PMID: 26088589 RESULT

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• José García de la Asunción, MD, PhD

  Instituto de Investigador Sanitaria, INCLIVA

  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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share