Comparison of the Effect of Low and High Fraction of Inspired Oxygen on Postoperative Surgical Field Infection

Supratentorial Brain Tumor Clinical Trial

Official title:

Comparison of the Effect of Low and High Fraction of Inspired Oxygen on Postoperative Surgical Field Infection and Pulmonary Complications in Patients Undergoing Supratentorial Craniotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03454659
• Other study ID #: 83045809-604.01.02-
• Status: Not yet recruiting
• Phase: N/A
• First received: January 17, 2018
• Last updated: March 4, 2018
• Start date: April 2018
• Est. completion date: April 2020

Study information

• Verified date: March 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

*fraction of inspired oxygen

Description:

The aim of the study is to compare effects of high 0.8 FiO2 and low 0.4 FiO2 in patients are undergoing supratentorial craniotomy surgery primarily on postoperative surgical wound infection and secondarily on postoperative pulmonary complications.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA class 1-3

Exclusion Criteria:

• Obstructive and restrictive lung disease

• Chest wall deformity

• Chronical heart failure

• Liver and kidney failure

• Preoperative fever and infection history

• Important malnutrition

• Diabetes mellitus

Related Conditions & MeSH terms

• Supratentorial Brain Tumor

Intervention

Procedure:
• Craniotomy
Extracting the part of the sculpt

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of surgical field infection will be evaluated by ASEPSIS score.	Table 1 ASEPSIS SCORE. Proportion of wound affected (%) Wound characteristic 0 <20 20-39 40-50 60-79 >80; Serous exudate 0 1 2 3 4 5 Erythema 0 1 2 3 4 5 Purulent exudate 0 2 4 6 8 10 Separation of deep tissues 0 2 4 6 8 10; Criterion Points Additional treatment Antibiotics 10 Drainage of pus under local anesthesia 5 Debridement of wound (general anaesthesia) 10 Serous discharge daily 0-5 Erythema daily 0-5 Purulent exudate daily 0-10 Separation of deep tissues daily 0-10 Isolation of bacteria 10 Stay as inpatient prolonged over 14 days 5; Total score Infection category 0-10 Satisfactory healing 11-20 Disturbance of healing 21-30 Minor wound healing 31-40 Moderate wound infection. >40 Severe wound infection	2 years
Secondary	The rate of postoperatively pulmonary complications such as pneumonia,respiratory failure will be evaluated.Centers for Disease Control and Prevention criteria will be used for defining nosocomial pneumonia.	The diagnosis of respiratory failure will be perform by reduction of SpO2 = 90% although oxygen treatment and/or need for noninvasive or invasive mechanical ventilation.	2 years

External Links

•   Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial.
•   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.
•   Oxygen concentration and characteristics of progressive atelectasis formation during anaesthesia.
•   Supplemental Perioperative Oxygen to Reduce the Incidence of Surgical-Wound Infection
•   WHO Needs High FIO2?
•   Wound hypoxia and acidosis limit neutrophil bacterial killing mechanisms.