Predictive Value of Ariscat Index In The Development of Pulmonary Complication After Major Abdominal Cancer Surgery

Cancer Clinical Trial

Official title:

Predictive Value of Ariscat Risk Index In The Development of Postoperative Pulmonary Complication After Major Abdominal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663958
• Other study ID #: 2019-11/459
• Status: Completed
• Start date: December 21, 2020
• Est. completion date: August 18, 2021

Study information

• Verified date: November 2022
• Source: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: August 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Atelectasis
• Cancer
• Pneumonia
• Postoperative Complications
• Pulmonary Atelectasis
• Pulmonary Complication

Intervention

Diagnostic Test:
• Detection / Screening
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.

Locations

Country	Name	City	State
Turkey	Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

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. — View 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. — View Citation

Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002. Review. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the ARISCAT risk scoring index	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	Correlation between age (years) and PPC	Whether there is a correlation between age (years) and PPC	postoperative first 30 days
Secondary	Correlation between gender(male or female) and PPC	Whether there is a correlation between gender (male or female) and PPC	postoperative first 30 days
Secondary	Correlation between BMI (kg/m^2) and PPC	Whether there is a correlation between BMI (kg/m^2) and PPC	postoperative first 30 days
Secondary	Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC	Whether there is a correlation between smoking level (packs/year) and PPC	postoperative first 30 days
Secondary	Correlation between ASA physical score (1-4) and PPC	Whether there is a correlation between ASA physical score (1-4) and PPC	postoperative first 30 days
Secondary	Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC	Whether there is a correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC	postoperative first 30 days
Secondary	Correlation between preoperative hemoglobulin values (gram / deciliter) and PPC	Whether there is a correlation between preoperative hemoglobulin values (gram / deciliter) and PPC	postoperative first 30 days
Secondary	Correlation between surgical incision side (lower-upper abdominal) and PPC	Whether there is a correlation between surgical incision side (lower-upper abdominal) and PPC	postoperative first 30 days
Secondary	Correlation between laparoscopic or open surgery and PPC	Whether there is a correlation between laparoscopic or open surgery and PPC	postoperative first 30 days
Secondary	Correlation between , emergency or elective surgery and PPC	Whether there is a correlation between , emergency or elective surgery and PPC	postoperative first 30 days
Secondary	Correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC	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
Secondary	Correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC	Whether there is a correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC	postoperative first 30 days