Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

NCT ID: NCT02671721

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-30

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.

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.

Conditions

Complication of Ventilation Therapy; Postoperative Respiratory Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Conventional Strategy

Patients will receive usual and prudent PEEP and tidal volume settings.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Maximal Compliance Strategy

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

Group Type: EXPERIMENTAL

Maximal Compliance

Intervention Type: OTHER

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

Transpulmonary Pressure Strategy

Personal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port

Group Type: EXPERIMENTAL

Transpulmonary Pressure

Intervention Type: OTHER

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

Interventions

Maximal Compliance

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

Intervention Type: OTHER

Transpulmonary Pressure

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marcos Vidal Melo

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Fernandez-Bustamante A, Sprung J, Parker RA, Bartels K, Weingarten TN, Kosour C, Thompson BT, Vidal Melo MF. Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):383-392. doi: 10.1016/j.bja.2020.06.030. Epub 2020 Jul 16.

Reference Type: DERIVED

PMID: 32682559 (View on PubMed)

Other Identifiers

2015P001613

Identifier Type: -

Identifier Source: org_study_id