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出境医 / 临床实验 / Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Study Description
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Malignant Surgical Procedures, Operative Stomach Neoplasms Pancreatic Cancer, Adult Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
Primary Purpose: Screening
Official Title: Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
Study Start Date : January 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. Number of the patients with postoperative pneumonia [ Time Frame: Postoperative day 4 ]
    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.

  2. Number of the patients with productive cough and difficult expectoration [ Time Frame: Postoperative day 4 ]
    patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia

  3. Number of the patients with hoarseness [ Time Frame: Postoperative day 4 ]
    The patients who self-reported hoarseness and changed voice


Secondary Outcome Measures :
  1. One year survival and complications [ Time Frame: One postoperative year ]
    All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Sponsors and Collaborators
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Investigators
Layout table for investigator information
Principal Investigator: Slavica Kvolik, MD, PhD Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date July 2, 2019
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Number of the patients with postoperative pneumonia [ Time Frame: Postoperative day 4 ]
    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.
  • Number of the patients with productive cough and difficult expectoration [ Time Frame: Postoperative day 4 ]
    patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia
  • Number of the patients with hoarseness [ Time Frame: Postoperative day 4 ]
    The patients who self-reported hoarseness and changed voice
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
One year survival and complications [ Time Frame: One postoperative year ]
All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
Official Title  ICMJE Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Neoplasms Malignant
  • Surgical Procedures, Operative
  • Stomach Neoplasms
  • Pancreatic Cancer, Adult
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
  • 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.

    Intervention: Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
Publications *
  • Evaristo-Méndez G, Rocha-Calderón 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.
  • 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.
  • 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. 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2019)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002128
Other Study ID Numbers  ICMJE 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Upon the request all blinded individual participant data (IPD) may be available to other researchers
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Upon the request
Access Criteria: Shared by principal investigator directly
Responsible Party Osijek University Hospital
Study Sponsor  ICMJE Osijek University Hospital
Collaborators  ICMJE Josip Juraj Strossmayer University of Osijek
Investigators  ICMJE
Principal Investigator: Slavica Kvolik, MD, PhD Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
PRS Account Osijek University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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