Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

NCT02671721 | Completed DMC

• 1 other identifier: 2015P001613
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Ventilation Therapy; Postoperative Respiratory Complications

Outcome Measures

Primary Outcomes (4)

• Intraoperative driving pressure

  We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.

  During abdominal surgery

• Intraoperative transpulmonary pressure

  We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.

  During abdominal surgery

• Intraoperative respiratory system compliance

  We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.

  During abdominal surgery

• 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 Outcomes (3)

• Intraoperative gas exchange

  During abdominal surgery

• Plasma levels of biomarkers of lung injury

  During abdominal surgery

• Postoperative Pulmonary Complications

  Within the first 7 postoperative days.

Study Arms (3)

Conventional Strategy

NO INTERVENTION

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

Maximal Compliance Strategy

EXPERIMENTAL

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

Other: Maximal Compliance

Transpulmonary Pressure Strategy

EXPERIMENTAL

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

Other: Transpulmonary Pressure

Interventions

Maximal Compliance OTHER

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

Maximal Compliance Strategy

Transpulmonary Pressure OTHER

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

Transpulmonary Pressure Strategy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mayo Clinic: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 32682559 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: February 2, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (1)