Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000211460
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
16/02/2016
Date last updated
6/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of exhaled nitric oxide in patients with chronic obstructive pulmonary disease undergoing abdominal surgery
Scientific title
The role of exhaled nitric oxide in patients with chronic obstructive pulmonary disease undergoing abdominal surgery: evaluation of postoperative complications
Secondary ID [1] 287307 0
None
Universal Trial Number (UTN)
U1111-1178-7249
Trial acronym
NOXIOUS (exhaled Nitric OXIde in patients with chronic Obstructive pulmonary disease Undergoing Surgery)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
 297373 0
Post-operative complications following abdominal surgery 297593 0
Condition category
Condition code
Respiratory 297556 297556 0 0
Chronic obstructive pulmonary disease
Surgery 297720 297720 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperative examination for patients scheduled for major abdominal surgeries with diagnosis of COPD for:
- FEV1%pred (the predicted amount as a percentage of the forced expiratory lung volume in one second) using a spirometric test according to the standard procedure
- the 6 minute walking distance test (6 MWD)
- the Modified Medical Research Council Dyspnoea Scale (MMRC).
- the body mass index (BMI)
In additional to all above standard care examinations all patients will be examined for exhaled NO measurement using a portable NO analyzer.
All the examinations will be performed from an experienced anesthetist, within 1 week prior to surgery.
The approximate duration of preoperative examinations is 1 hour.

All patients are administered premedication with diazepam 5mg orally in the evening and in the morning before surgery.
The induction of anesthesia includes intravenous infusion of midazolam 2,5 mg, 0,1mg fentanyl, propofol 2-2,5 mg/kg and rocuronium 0,6 mg/kg.
Perioperative monitoring includes ECG, blood pressure measurement, Central Venous Pressure measurement, pulse oximeter and capnograph.
Postoperatively all complications are recordeded as laryngospasm, bronchospasm, cough, dyspnea and tachypnea as well as the need for corticosteroids or bronchodilators administration.
The values of blood gases 1 and 3 hours postoperatively as well as 3 days after surgery are recorded.
Intervention code [1] 293674 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297112 0
The aim of this study was to evaluate the relationship between exhaled NO in COPD patients undergoing major abdominal surgeries and the risk of presenting postoperative complications
The postoperative complications as laryngospasm, bronchospasm, cough, dyspnea and tachypnea will be assessed using clinical examination combined with the recorded use of corticosteroids and bronchodilators.
The values of blood gases 1 and 3 hours postoperatively as well 3 days after surgery will be recorded using a blood gas analyzer.
Timepoint [1] 297112 0
Perioperatively and 1-3 days postoperatively
Secondary outcome [1] 320044 0
To evaluate the diagnostic performance of exhaled NO combined with the classic clinical and laboratory evaluation tests
The evaluation will be achieved after comparing the complication incidence and correlating the results with exhaled NO values, FEV1%pred (the predicted amount as a percentage of the forced expiratory lung volume in one second), the 6MWD test, the MMRC and the BODE Index scores.
The postoperative complications as laryngospasm, bronchospasm, cough, dyspnea and tachypnea will be assessed using clinical examination combined with the recorded use of corticosteroids and bronchodilators.
The values of blood gases 1 and 3 hours postoperatively as well 3 days after surgery will be recorded using a blood gas analyzer.
Timepoint [1] 320044 0
- NO values, FEV1%pred, 6MWD test, MMRC, BODE Index scores:1-2 days preoperatively
- Laryngospasm, bronchospasm, cough, dyspnea and tachypnea using clinical examination combined with the recorded use of corticosteroids and bronchodilators, values of blood gases :perioperatively
- FEV1%pred, Laryngospasm, bronchospasm, cough, dyspnea and tachypnea using clinical examination combined with the recorded use of corticosteroids and bronchodilators, values of blood gases: 1-3 days postoperatively
Secondary outcome [2] 320454 0
To evaluate the diagnostic performance of exhaled NO for the identification of not well-controlled COPD surgical patients The maximun exhaled NO value for normal patients is defined as 15 while pathological is 16 or more. Patients in one group have well-controlled COPD defined by a NO value of 18 or less while patients from other group have not-well controlled COPD defined by a NO value of 19 or more The evaluation will be achieved after comparing the complication incidence between two groups. The postoperative complications as laryngospasm, bronchospasm, cough, dyspnea and tachypnea will be assessed using clinical examination combined with the recorded use of corticosteroids and bronchodilators. The values of blood gases 1 and 3 hours postoperatively as well 3 days after surgery will be recorded using a blood gas analyzer.
Timepoint [2] 320454 0
- NO values, FEV1%pred, 6MWD test, MMRC, BODE Index scores:1-2 days preoperatively
- Laryngospasm, bronchospasm, cough, dyspnea and tachypnea using clinical examination combined with the recorded use of corticosteroids and bronchodilators, values of blood gases :perioperatively
- FEV1%pred, Laryngospasm, bronchospasm, cough, dyspnea and tachypnea using clinical examination combined with the recorded use of corticosteroids and bronchodilators, values of blood gases: 1-3 days postoperatively

Eligibility
Key inclusion criteria
Patients scheduled for major abdominal surgeries that were evaluated from an experienced physician were enrolled for the study.
The inclusion criteria are:
- age 18-75 years
- a diagnosis of COPD according to the American Thoracic Society (ATS) criteria in a stable condition and free from exacerbations in the preceding four weeks
- ASA physical status II, III, IV
- Smoking patients
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with:
- other organ failure
- cancer
- inability to cooperate
- patients with a recent exacerbation (e.g. requiring hospitalization or oral corticosteroids)
- patients with another or coexisting respiratory disorder (e.g. COPD and bronchiectasis)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All statistics will be using SPSS statistical package for Windows, version 22.0.
Normally distributed data will be presented as mean +/- SE.
Comparisons between groups for non parametric data will be performed with Kruskall Wallis test followed by Dunn’s post-hoc tests.
Parametric data will be analyzed using ANOVA and the post hoc test with Bonferroni correction used when requested.
A p value of <0.05 will be considered significant.
In order to specify the number of participants needed to achieve statistical significant measuremets a power analysis was conducted using the results obtained from 10 first patients. According to those results, in order to have a power of 0.8-0.9 in our results the essential number of patients is approximately 100.
The significance level p=0.05 is also used in the sample size calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
29/02/2016
Actual
31/01/2016
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
100
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 7541 0
Greece
State/province [1] 7541 0

Funding & Sponsors
Funding source category [1] 292726 0
University
Name [1] 292726 0
Faculty of Medicine, University of Thessaly
Country [1] 292726 0
Greece
Primary sponsor type
University
Name
Faculty of Medicine, University of Thessaly
Address
University of Thessaly
Argonafton & Filellinon,
38221 Volos,
Magnesia
Greece
Country
Greece
Secondary sponsor category [1] 291457 0
None
Name [1] 291457 0
Address [1] 291457 0
Country [1] 291457 0
Other collaborator category [1] 278780 0
Hospital
Name [1] 278780 0
Achillopouleion General Hospital of Volos
Address [1] 278780 0
Polymeri 134, 38222, Volos, Magnesia
Country [1] 278780 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294213 0
Achillopouleion General Hospital of Volos Ethics Committee
Ethics committee address [1] 294213 0
Polymeri 134, 38222, Volos, Magnesia
Ethics committee country [1] 294213 0
Greece
Date submitted for ethics approval [1] 294213 0
01/04/2014
Approval date [1] 294213 0
20/08/2014
Ethics approval number [1] 294213 0
222a- 6/2-04-2014

Summary
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) has been associated with major perioperative morbidities or mortalities especially in surgical patients receiving general anesthesia. The severity of the COPD and the degree of bronchial hyperreactivity will determine the perioperative anesthetic risk, therefore they have to be assessed by a thorough preoperative evaluation in order to give the rationale on which to decide for the adequate anaesthetic techniques. Increased levels of exhaled nitric oxide (eNO) have been reported in patients with advanced chronic obstructive pulmonary disease (COPD).
The present study investigates if the levels of exhaled NO in patients with COPD can predict the risk for complications after surgery under general anesthesia.
Values of exhaled NO are evaluated in patients diagnosed with COPD scheduled for surgery under general anesthesia. COPD is evaluated using BODE Index score based on the Modified MRC Dyspnoea Scale, the BMI and the 6 MWD combined with the forced expiratory volume in one second (FEV1) parameter.
All patients are closely observed for presenting respiratory complications postoperatively.
Trial website
Trial related presentations / publications
The trial was published in Journal "Nitric Oxide". as:
Logotheti H, Pourzitaki C, Tsaousi G, Aidoni Z, Vekrakou A, Ekaterini A,
Gourgoulianis K. The role of exhaled nitric oxide in patients with chronic
obstructive pulmonary disease undergoing laparotomy surgery - The noxious study.
Nitric Oxide. 2016 Dec 30;61:62-68. doi: 10.1016/j.niox.2016.10.005. Epub 2016
Oct 19. PubMed PMID: 27771417.
Public notes
Attachments [1] 718 718 0 0
/AnzctrAttachments/369145-ethics.pdf

Contacts
Principal investigator
Name 59638 0
Dr Helena Logotheti
Address 59638 0
Clinic of Anesthesiology,
Achillopouleion General Hospital of Volos,
Polymeri 134, 38222, Volos, Magnesia,
Greece
Country 59638 0
Greece
Phone 59638 0
+306977443244
Fax 59638 0
Email 59638 0
[email protected]
Contact person for public queries
Name 59639 0
Dr Chryssa Pourzitaki
Address 59639 0
Clinic of Anesthesiology and Intensive Care Unit,
University Hospital AHEPA,
University Campus, 54124
Faculty of Medicine, School of Health Sciences,
Aristotle University of Thessaloniki
Greece
Country 59639 0
Greece
Phone 59639 0
+306945492971
Fax 59639 0
Email 59639 0
[email protected]
Contact person for scientific queries
Name 59640 0
Dr Chryssa Pourzitaki
Address 59640 0
Clinic of Anesthesiology and Intensive Care Unit,
University Hospital AHEPA,
University Campus, 54124
Faculty of Medicine, School of Health Sciences,
Aristotle University of Thessaloniki
Greece
Country 59640 0
Greece
Phone 59640 0
+306945492971
Fax 59640 0
Email 59640 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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