- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663958
Predictive Value of Ariscat Index In The Development of Pulmonary Complication After Major Abdominal Cancer Surgery
Predictive Value of Ariscat Risk Index In The Development of Postoperative Pulmonary Complication After Major Abdominal Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pulmonary complications (PPC) are one of the major causes of postoperative morbidity and mortality. Mortality and morbidity are 14-30% in patients with PPC, while it is 0.2-3% in patients without PPC. Its incidence is variable (<1% to 19%) and is more common than cardiac complications. Unfortunately, PPCs prolong the hospital stay significantly (up to 13-17 days), which means postoperative delirium, infection, and cost increase. The causes of PPCs are varied, and their physiopathology is well explained [3]. However, the rate of risk identification and scoring is not known. The synergistic effects of the patient's medical condition, general anesthesia, and surgery type on the respiratory system complicate the problem.The surgical approach, anesthesia method, and preoperative risk factors of the patients play an important role in the development of PPC.
This study was conducted after the approval from Dr. Abdurrahman Yurtaslan Oncology SUAM Ethics Committee in Ankara, Turkey (Between December 2020 - July 2021) (Ethics Committee Decision No: 2019-11 / 459). After informing all the patients included in the study, verbal and written consent were obtained. 410 patients over 18 years of age, who were scheduled for general anesthesia and whose ASA physical score was 1-4, were included in the study.
Demographic data of the patients, preoperative antibiotic prophylaxis, chronic diseases, ASA scores, preoperative hemoglobulin values, functional status, history of pulmonary system disease in the last 30 days, history of smoking and the amount of cigarette consumption, history of steroid use, chemotherapy and radiotherapy history, anesthesia method, surgical incision side (lower-upper abdominal), premedication status, intraoperative ventilation parameters (tidal volume, PEEP, peak pressure, fiO2 ratio), pneumoperitoneum pressure, amount of colloid / crystalloid product used, erythrocyte suspension and amount used, laparoscopic or open surgery, emergency or elective surgery, the duration of operation, and postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) were recorded. The ARISCAT risk assessment scores of the patients were also evaluated and recorded preoperatively.
The patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality. Postoperative pulmonary complications were defined by the development of one of the following new findings. The European Perioperative Clinical Outcome Definitions (EPCO) were used for this definition.
These findings; Respiratory Failure, Respiratory infection, Aspiration Pneumonia, Pleural effusion, Pneumothorax, Atelectasis, Bronchoconstriction, Pneumonia, ARDS, Pulmonary Embolism, Pulmonary Edema, Unplanned emergency re-intubation, Leaving as intubated from the operation room.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years of age
- Who were scheduled for general anesthesia
- Whose ASA physical score was 1-4
Exclusion Criteria:
- ASA physical status> 4
- Pregnant women
- Intubated patients before the operation
- Patients who had surgery due to a previous surgical complication
- Severe cardiovascular disease
- Severe hemodynamic instability
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of the ARISCAT risk scoring index
Time Frame: postoperative first 7 days
|
to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing major abdominal cancer surgery
|
postoperative first 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between age (years) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between age (years) and PPC
|
postoperative first 30 days
|
|
Correlation between gender(male or female) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between gender (male or female) and PPC
|
postoperative first 30 days
|
|
Correlation between BMI (kg/m^2) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between BMI (kg/m^2) and PPC
|
postoperative first 30 days
|
|
Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between smoking level (packs/year) and PPC
|
postoperative first 30 days
|
|
Correlation between ASA physical score (1-4) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between ASA physical score (1-4) and PPC
|
postoperative first 30 days
|
|
Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC
|
postoperative first 30 days
|
|
Correlation between preoperative hemoglobulin values (gram / deciliter) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between preoperative hemoglobulin values (gram / deciliter) and PPC
|
postoperative first 30 days
|
|
Correlation between surgical incision side (lower-upper abdominal) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between surgical incision side (lower-upper abdominal) and PPC
|
postoperative first 30 days
|
|
Correlation between laparoscopic or open surgery and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between laparoscopic or open surgery and PPC
|
postoperative first 30 days
|
|
Correlation between , emergency or elective surgery and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between , emergency or elective surgery and PPC
|
postoperative first 30 days
|
|
Correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC
|
postoperative first 30 days
|
|
Correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC
Time Frame: postoperative first 30 days
|
Whether there is a correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC
|
postoperative first 30 days
|
Collaborators and Investigators
Investigators
- Study Director: MUSTAFA KEMAL SAHIN, Dr, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Publications and helpful links
General Publications
- Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499.
- Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.
- Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.
- Perilli V, Aceto P, Ancona P, De Cicco R, Papanice D, Magalini S, Pepe G, Cozza V, Gui D, Lai C, Sollazzi L. Role of surgical setting and patients-related factors in predicting the occurrence of postoperative pulmonary complications after abdominal surgery. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2):547-550. doi: 10.26355/eurrev_201801_14208.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pathological Conditions, Signs and Symptoms
- Neoplasms
- Pneumonia
- Pulmonary Atelectasis
- Postoperative Complications
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Diagnostic Services
- Health Surveys
- Surveys and Questionnaires
- Public Health Practice
- Mass Screening
Other Study ID Numbers
- 2019-11/459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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