Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms; Surgical Procedures, Operative; Colorectal Neoplasms Malignant; Pancreatic Cancer, Adult
• Intervention / Treatment: Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group air; Group air was mechanically ventilated using 35% oxygen in 65% air during the whole surgical procedure. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses.	Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.; Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.
Active Comparator: Group nitrous oxyde (N2O); Group N2O was mechanically ventilated using 35 % oxygen and 65 % of nitrous oxyde during the surgical procedure. Nitrous oxyde may increase cuff pressure during the general endotracheal anesthesia and result in the respiratory symptoms like sore throat, hoarseness and postoperative cough. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses.	Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.; Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the patients with postoperative pneumonia	Number of patients who reported the presence of cough, dyspnea and/or abnormal findings on lung examination, and two of following: fever, leukocytosis or high CRP, and positive chest radiograms.	Postoperative day 4
Number of the patients with productive cough and difficult expectoration	patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia	Postoperative day 4
Number of the patients with hoarseness	The patients who self-reported hoarseness and changed voice	Postoperative day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One year survival and complications	All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.	One postoperative year

Collaborators and Investigators

• Sponsor: Osijek University Hospital
• Collaborators: Josip Juraj Strossmayer University of Osijek
• Investigators: Principal Investigator: Slavica Kvolik, MD, PhD, Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Survival; tracheal colonization;; Bacteria;; Anesthesia, General
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Stomach Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon the request all blinded individual participant data (IPD) may be available to other researchers
• IPD Sharing Time Frame: Upon the request
• IPD Sharing Access Criteria: Shared by principal investigator directly
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No