Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

NCT04002128 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Neoplasms Malignant; Surgical Procedures, Operative; Stomach Neoplasms; Pancreatic Cancer, Adult

Keywords

tracheal colonization;; Bacteria;; Survival; Anesthesia, General;

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• One year survival and complications

  One postoperative year

Study Arms (2)

Group air

PLACEBO COMPARATOR

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.

Group nitrous oxyde (N2O)

ACTIVE COMPARATOR

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.

Interventions

Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. OTHER

Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

Group air; Group nitrous oxyde (N2O)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead
• Josip Juraj Strossmayer University of Osijek: collaborator

Related Publications (5)

• 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.

  PMID: 26259742 BACKGROUND

• 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.

  PMID: 27829093 BACKGROUND

• 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.

  PMID: 11412514 BACKGROUND

• 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.

  PMID: 8494136 BACKGROUND

• 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.

  PMID: 15374551 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Pancreatic cancer, adult

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Slavica Kvolik, MD, PhD

  Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 28, 2019
• Study Start: January 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 23, 2024

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon the request
• Access Criteria: Shared by principal investigator directly