Clinical trial NCT04002128: Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
Official title: Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms Malignant
Surgical Procedures, Operative
Stomach Neoplasms
Pancreatic Cancer, Adult
Keywords: tracheal colonization;
Bacteria;
Survival
Anesthesia, General;
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
Collaborators: name: Josip Juraj Strossmayer University of Osijek
First posted: 2019-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To investigate whether productive cough, dyspnea and hoarseness were different between two groups of patients. Group Air received sevoflurane anesthesia with 35% O2 in air, and Group N2O received sevoflurane anesthesia with 35% O2 in N2O
Primary purpose: SCREENING

Brief summary: The goals of this study were to investigate whether two anesthesia regimens, with and without N2O, and bacterial colonization influence respiratory complications after major abdominal surgery for cancer.

Detailed description: A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed.

A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system.

Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day.

Outcome measures registered were:

* Postoperative pneumonia
* Productive and difficult cough
* Dysphonia
* Congestive heart failure
* postoperative complications, including hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished \& one year survival

Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosis of gastric cancer, or colorectal cancer or pancreatic cancer
* Scheduled for major abdominal surgery with organ resections
* Written informed consent
* Nasopharyngeal smears taken in the preoperative area
* Tracheal aspirates taken at the end of the surgical procedure

Exclusion Criteria:

* Patients unable to understand study protocol and patients who refused study participation at any time
* patients with clinically or radiologically confirmed acute respiratory infections at admission
* antibiotic therapy due to the respiratory infections a week prior to the surgery

Primary outcomes:
measure: Number of the patients with postoperative pneumonia
timeFrame: Postoperative day 4
measure: Number of the patients with productive cough and difficult expectoration
timeFrame: Postoperative day 4
measure: Number of the patients with hoarseness
timeFrame: Postoperative day 4
Secondary outcomes:
measure: One year survival and complications
timeFrame: One postoperative year
Other outcomes:
Locations:
Study officials:
affiliation: Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
name: Slavica Kvolik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evaristo-Mendez G, Rocha-Calderon CH. [Risk factors for nosocomial pneumonia in patients with abdominal surgery]. Cir Cir. 2016 Jan-Feb;84(1):21-7. doi: 10.1016/j.circir.2015.05.051. Epub 2015 Aug 8. Spanish.
citation: Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
citation: de Albuquerque Medeiros R, Faresin S, Jardim J. [Postoperative lung complications and mortality in patients with mild-to-moderate COPD undergoing elective general surgery]. Arch Bronconeumol. 2001 May;37(5):227-34. doi: 10.1016/s0300-2896(01)75059-4. Spanish.
citation: Payne KA, Miller DM. The Miller tracheal cuff pressure control valve. Clinical use in controlled and spontaneous ventilation. Anaesthesia. 1993 Apr;48(4):324-7. doi: 10.1111/j.1365-2044.1993.tb06954.x.
citation: Braz JR, Volney A, Navarro LH, Braz LG, Nakamura G. Does sealing endotracheal tube cuff pressure diminish the frequency of postoperative laryngotracheal complaints after nitrous oxide anesthesia? J Clin Anesth. 2004 Aug;16(5):320-5. doi: 10.1016/j.jclinane.2004.03.001.