Clinical trial NCT04663958: Predictive Value of Ariscat Index In The Development of Pulmonary Complication After Major Abdominal Cancer Surgery
Official title: Predictive Value of Ariscat Risk Index In The Development of Postoperative Pulmonary Complication After Major Abdominal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Cancer
Pulmonary Complication
Atelectasis
Abdominal Surgery
Pneumonia
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 420 patients operated in General Surgery, Urology, and Gynecological Oncology departments were included in the study. Seven of these patients were excluded from the study because they did not sign the written consent, and three patients were excluded due to a lack of data.

Brief summary: The term postoperative pulmonary complication is the development of any complications affecting the respiratory system after anesthetic and surgery procedures. The ARISCAT risk assessment score is a seven-variable regression model that divides patients into low, moderate, and high-risk groups. In this study, the investigators aimed to investigate the effectiveness of the ARISCAT risk scoring index in predicting postoperative pulmonary complication development in patients scheduled for major abdominal cancer surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years of age
2. Who were scheduled for general anesthesia
3. Whose ASA physical score was 1-4

Exclusion Criteria:

1. ASA physical status\> 4
2. Pregnant women
3. Intubated patients before the operation
4. Patients who had surgery due to a previous surgical complication
5. Severe cardiovascular disease
6. Severe hemodynamic instability

Primary outcomes:
measure: Effectiveness of the ARISCAT risk scoring index
timeFrame: postoperative first 7 days
Secondary outcomes:
measure: Correlation between age (years) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between gender(male or female) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between BMI (kg/m^2) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between ASA physical score (1-4) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between preoperative hemoglobulin values (gram / deciliter) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between surgical incision side (lower-upper abdominal) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between laparoscopic or open surgery and PPC
timeFrame: postoperative first 30 days
measure: Correlation between , emergency or elective surgery and PPC
timeFrame: postoperative first 30 days
measure: Correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC
timeFrame: postoperative first 30 days
measure: Correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC
timeFrame: postoperative first 30 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
state: Yenimahalle
Study officials:
affiliation: Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
name: MUSTAFA KEMAL SAHIN, Dr
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
citation: 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.