Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

Complication of Ventilation Therapy Clinical Trial

Official title:

Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671721
• Other study ID #: 2015P001613
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Postoperative Respiratory Complications

Intervention

Other:
• Maximal Compliance
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
• Transpulmonary Pressure
We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mayo Clinic, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative driving pressure	We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.	During abdominal surgery
Primary	Intraoperative transpulmonary pressure	We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.	During abdominal surgery
Primary	Intraoperative respiratory system compliance	We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.	During abdominal surgery
Primary	Intraoperative positive end-expiratory pressure (PEEP) levels	We will assess intraoperative PEEP values and their variability between patients and during surgery.	During abdominal surgery
Secondary	Intraoperative gas exchange	We will assess intraoperative oxygenation and carbon dioxide elimination.	During abdominal surgery
Secondary	Plasma levels of biomarkers of lung injury	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).	During abdominal surgery
Secondary	Postoperative Pulmonary Complications	We will assess the incidence and absolute number of postoperative pulmonary complications within the first 7 postoperative days.	Within the first 7 postoperative days.