Comparison of the Effect of Low and High Fraction of Inspired Oxygen on Postoperative Surgical Field Infection
NCT ID: NCT03454659
Last Updated: 2018-03-06
Study Results
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Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2018-04-30
2020-04-30
Brief Summary
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\*fraction of inspired oxygen
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Detailed Description
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The study will be performed prospectively in patient are undergoing elective supratentorial craniotomy with supine position at Istanbul university Cerrahpasa Medical School Department of Neurosurgery operating room. ASA class I-III 80 patients will be included the study. Exclusion criteria are obstructive or restrictive lung disease, chest wall deformity, congestive heart failure, liver or kidney failure, postoperatively non-cooperative and unconsciousness, preoperative fever and infection history, serious malnutrition( plasma albumin level \< 3 g/dl, WBC \<2500/mm3 or weight loss more than 20% in 3 months),and diabetes mellitus.
The gender, age, height, weight, BMI, smoking history and systemically illness of patients will be recorded. Patients will be randomized with closed envelop technique and divided in 2 groups. All patients will be monitored ECG, heart rate, invasive blood pressure , FiO2,pulse oximetry (SpO2) and end tidal carbon dioxide . Propofol (2 mg kg-1), remifentanyl (0.15 µ kg-1), rocuronium (0.6 mg kg-1) will be used for induction in both groups. Anesthesia maintenance will be provided with sevoflurane (1 MAC), remifentanyl (0.05-0.1 µ kg-1 dk-1) and rocuronium (0.3 mg kg-1 sa-1) . Patients will be intubated orotracheally and ventilated with volume control mode ( tidal volume 8 mL/kg, respiratory frequency will be adjusted between 9-12/minutes to hold PaCO2 between 33-35 mmHg ,inspiration/expiration ratio ½,PEEP:5 cmH2O ). Peroperative analgesia will be provided with remifentanyl infusion. Ondansetron 8 mg for antiemesis and tramadol 100 mg for postoperative analgesia will be administered intravenously 30 minutes before extubation. Duration of surgery and non-invasive cerebral oxygen saturation (SctO2) using bilateral frontal electrodes will be recorded. At the end of the surgery, sugammadex 2mg kg-1 will be administered for decurarization in all groups. Patients will be transferred to the recovery room in postoperative period and 15L/min and 4L/min oxygen will be given to 0.8 FiO2 group and other group, respectively.
Wound healing will be evaluated every day in terms of surgical wound infection occurrence for postoperative 14 days with ASEPSIS classification. Surgical wound infection will be considered in patients who score 20 or more on daily basis. The patients who are discharged will be reached by phone. Pneumonia, atelectasis, respiratory failure, hospital and intensive care unit stay will be recorded for postoperative 14 days. \*CDC criteria will be used to diagnose pneumonia. Respiratory insufficiency is diagnosed by SpO2 fall below 90% despite oxygen treatment and mechanical ventilation need. If pulmonary complication develops ,findings will be recorded with chest radiography or tomography when necessary.
* ASA: american society of anaesthesiology
* WBC:white blood cell
* PEEP: positive end expiratory pressure
* CDC: centers for disease control and prevention
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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high (0.8 )
The purpose of this study is to compare the effect of high 0.8 and low 0.4 FiO2 ventilation primarily on surgical field infection and secondarily on postoperative pulmonary complications in patients are undergoing supratentorial craniotomy surgeons.
Craniotomy
Extracting the part of the sculpt
low (0,4) fiO2
The purpose of this study is to compare the effect of high 0.8 and low 0.4 FiO2 ventilation primarily on surgical field infection and secondarily on postoperative pulmonary complications in patients undergoing supratentorial craniotomy surgeons.
Craniotomy
Extracting the part of the sculpt
Interventions
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Craniotomy
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chest wall deformity
* Chronical heart failure
* Liver and kidney failure
* Preoperative fever and infection history
* Important malnutrition
* Diabetes mellitus
18 Years
70 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Mustafa Aydın
Research Assistant
Related Links
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High-concentration supplemental perioperative oxygen to reduce the incidence of postcesarean surgical site infection: a randomized controlled trial.
New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective.
Supplemental Perioperative Oxygen to Reduce the Incidence of Surgical-Wound Infection
Wound hypoxia and acidosis limit neutrophil bacterial killing mechanisms.
WHO Needs High FIO2?
Oxygen concentration and characteristics of progressive atelectasis formation during anaesthesia.
Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial.
Other Identifiers
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83045809-604.01.02-
Identifier Type: -
Identifier Source: org_study_id
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