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Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position

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ClinicalTrials.gov Identifier: NCT02373475
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS). However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position. Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications. Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.

Condition or disease Intervention/treatment Phase
Pulmonary Complications Other: Conventional ventilation Other: Protective lung ventilation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Conventional ventilation
Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia
Other: Conventional ventilation
Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia

Active Comparator: Protective lung ventilation
Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia
Other: Protective lung ventilation
Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia




Primary Outcome Measures :
  1. forced vital capacity (FVC) [ Time Frame: 3 days after the spine surgery ]
    The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.

  2. forced expiratory volume in 1 second (FEV1) [ Time Frame: 3 days after the spine surgery ]
    The changes in the pulmonary functional tests [forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
  • the age: 19 yrs and older
  • the patients had a preoperative risk index for pulmonary complications of more than 2.

Exclusion Criteria:

  • Patients with altered mental status or increased intracranial pressure
  • Body mass index more than 35 kg/m2
  • Patients with persistent hemodynamic instability or intractable shock
  • Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
  • Recent history of invasive ventilation (within two weeks)
  • Recent history of pneumonia, ALI/ARDS or sepsis (within two weeks)
  • History of pulmonary resection, emphysema or chronic obstructive pulmonary disease (COPD)
  • Repeated systemic corticosteroid therapy for acute exacerbations of COPD or asthma
  • Recent immunosuppressive medication defined as need of chemotherapy or radiation therapy (within two months)
  • History of neuromuscular disease
  • Emergency operation
  • Patient refusal
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373475


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02373475     History of Changes
Other Study ID Numbers: 4-2014-0955
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Keywords provided by Yonsei University:
spine surgery
prone position
intraoperative lung protective strategies
postoperative pulmonary complications
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs