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Completed

NCT Number: NCT02671721

Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maximal Compliance

Other

PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.

Transpulmonary Pressure

Other

We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mayo Clinic
  • University of Colorado, Denver

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2016
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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