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

March 4, 2018 updated by: Mustafa Aydın, Istanbul University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Procedure: Craniotomy
Extracting the part of the sculpt

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the rate of surgical field infection will be evaluated by ASEPSIS score.
Time Frame: 2 years

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Publications and helpful links

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Helpful Links

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 83045809-604.01.02-

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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