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

NCT03454659 | Unknown DMC

• 1 other identifier: 83045809-604.01.02-
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Supratentorial Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  2 years

Study Arms (2)

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.

Procedure: Craniotomy

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.

Procedure: Craniotomy

Interventions

Craniotomy PROCEDURE

Extracting the part of the sculpt

high (0.8 ); low (0,4) fiO2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* ASA CLASS 1-3 * Patient age between 18-70 years

You may qualify if:

• ASA class 1-3

You may not qualify if:

• Obstructive and restrictive lung disease
• Chest wall deformity
• Chronical heart failure
• Liver and kidney failure
• Preoperative fever and infection history
• Important malnutrition
• Diabetes mellitus

Sponsors & Collaborators

• Istanbul University: lead

Related Links

• 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.
• 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.

MeSH Terms

Interventions

Craniotomy

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: March 6, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 6, 2018

Record last verified: 2018-03