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Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671721
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Mayo Clinic
University of Colorado, Denver
Information provided by (Responsible Party):
Marcos Vidal Melo, Massachusetts General Hospital

Brief Summary:
The purpose of this pilot study is to identify the optimal way to ventilate patients during abdominal surgery in order to reduce the amount of post-operative pulmonary complications in patients at moderate and high-risk for them.

Condition or disease Intervention/treatment Phase
Complication of Ventilation Therapy Postoperative Respiratory Complications Other: Maximal Compliance Other: Transpulmonary Pressure Not Applicable

Detailed Description:

The investigators plan to prospectively compare two methods to individualize Positive End Expiratory Pressure (PEEP) settings in the operating room during abdominal surgery: (1) Maximization of respiratory compliance during a decremental PEEP titration, and (2) Prevention of negative end-expiratory transpulmonary pressures.

The investigators will exploit the usual intraoperative requirement for a naso/orogastric tube to assess transpulmonary pressures,and respiratory mechanics measurements from anesthesia machines to titrate PEEP.

The investigators will measure biomarkers of lung injury and lung function to compare those methods between themselves and to the control group. In the process, the investigators will assess the ease and reliability of anesthesia teams in implementing the methods. These data will allow us to determine the PEEP strategy best suited for the full-scale trial, and to estimate the degree of separation the experimental lung protective approach will have from the protocolized usual care control settings.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
Actual Study Start Date : June 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
No Intervention: Conventional Strategy
Patients will receive usual and prudent PEEP and tidal volume settings.
Experimental: Maximal Compliance Strategy
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
Other: Maximal Compliance
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.

Experimental: Transpulmonary Pressure Strategy
Personal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port
Other: Transpulmonary Pressure
We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.




Primary Outcome Measures :
  1. Intraoperative driving pressure [ Time Frame: During abdominal surgery ]
    We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.

  2. Intraoperative transpulmonary pressure [ Time Frame: During abdominal surgery ]
    We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.

  3. Intraoperative respiratory system compliance [ Time Frame: During abdominal surgery ]
    We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.

  4. Intraoperative positive end-expiratory pressure (PEEP) levels [ Time Frame: During abdominal surgery ]
    We will assess intraoperative PEEP values and their variability between patients and during surgery.


Secondary Outcome Measures :
  1. Intraoperative gas exchange [ Time Frame: During abdominal surgery ]
    We will assess intraoperative oxygenation and carbon dioxide elimination.

  2. Plasma levels of biomarkers of lung injury [ Time Frame: During abdominal surgery ]
    We will assess plasma concentrations of biomarkers of lung injury before and after surgery, including biomarkers of inflammation (interleukin-6, IL-6, interleukin-8, IL-8), epithelial injury (soluble form of the receptor for advanced glycation end-products, sRAGE, Club Cell protein-16, CC16), endothelial injury (angiopoietin-2, Ang-2), and endothelial-derived coagulation activation (plasminogen activator inhibitor-1, PAI-1).

  3. Postoperative Pulmonary Complications [ Time Frame: Within the first 7 postoperative days. ]
    We will assess the incidence and absolute number of postoperative pulmonary complications within the first 7 postoperative days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ( 18 years) scheduled for elective surgery expected to last 2 h,
  • elective intraperitoneal abdominal or pelvic surgery including: gastric; biliary; pancreatic; hepatic; major bowel, ovarian, renal tract, bladder, and prostatic; radical hysterectomy; and pelvic exenteration;
  • at least intermediate risk of PPCs defined by a risk score 26

Exclusion Criteria:

  • Inability or refusal to provide consent
  • Refusal of clinicians caring for patient to follow the protocol
  • Participation in interventional investigation within 30 days of the time of the study
  • Pregnancy
  • Emergency surgery
  • Severe obesity (above Class I, BMI 35)
  • Significant lung disease: any diagnosed or treated respiratory condition that (a) requires home oxygen therapy or non-invasive ventilation, (b) severely limits exercise tolerance to <4 METs (e.g. patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs), or (c) required previous lung surgery80
  • Significant heart disease: cardiac conditions that limit exercise tolerance to <4 METs
  • Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine 2 mg/dL;
  • Neuromuscular disease that impairs ability to ventilate without assistance
  • Severe chronic liver disease (Child-Pugh Score of 10 -15)
  • Sepsis
  • Malignancy or other irreversible condition for which 6-month mortality is estimated 50%
  • Bone marrow transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671721


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Mayo Clinic
University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcos Vidal Melo, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02671721    
Other Study ID Numbers: 2015P001613
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No