Complication of Ventilation TherapyNCT02671721
Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
A study testing Maximal Compliance and Transpulmonary Pressure in people with Complication of Ventilation Therapy and Postoperative Respiratory Complications, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Complication of Ventilation Therapy, Postoperative Respiratory Complications
- What is being tested?
- Maximal Compliance and Transpulmonary Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Being tested
- Maximal Compliance, Transpulmonary Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal ComplianceOther
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
Transpulmonary PressureOther
We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Maximal Compliance |
| Transpulmonary Pressure Strategy | Experimental | Personal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port Receives: Other: Transpulmonary Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative driving pressure
We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.
Measured: During abdominal surgery
Intraoperative transpulmonary pressure
We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.
Measured: During abdominal surgery
Intraoperative respiratory system compliance
We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.
Measured: During abdominal surgery
Intraoperative positive end-expiratory pressure (PEEP) levels
We will assess intraoperative PEEP values and their variability between patients and during surgery.
Measured: During abdominal surgery
Secondary outcomes (3)
Intraoperative gas exchange
We will assess intraoperative oxygenation and carbon dioxide elimination.
Measured: During abdominal surgery
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).
Measured: During abdominal surgery
Postoperative Pulmonary Complications
We will assess the incidence and absolute number of postoperative pulmonary complications within the first 7 postoperative days.
Measured: Within the first 7 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Ventilation TherapyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Colorado, Denver
- Responsible party
- Principal investigator, Marcos Vidal Melo, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671721
- Sponsor's protocol ID
- 2015P001613
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32682559
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT02671721
- Acronym / sponsor ID
- 2015P001613
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Colorado, Denver
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Strategy | No intervention | –Patients will receive usual and prudent PEEP and tidal volume settings. |
| Maximal Compliance Strategy | Experimental | Other: Maximal CompliancePEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve. |
| Transpulmonary Pressure Strategy | Experimental | Other: Transpulmonary PressurePersonal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal CompliancePEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve. | Other | Maximal Compliance Strategy |
| Transpulmonary PressureWe will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively. | Other | Transpulmonary Pressure Strategy |
Primary outcome
Intraoperative driving pressure
Time frame: During abdominal surgery
We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.
Intraoperative transpulmonary pressure
Time frame: During abdominal surgery
We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.
Intraoperative respiratory system compliance
Time frame: During abdominal surgery
We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.
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.
3 secondary outcomes
Intraoperative gas exchange
Time frame: During abdominal surgery
Plasma levels of biomarkers of lung injury
Time frame: During abdominal surgery
Postoperative Pulmonary Complications
Time frame: Within the first 7 postoperative days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 32682559Fernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal Compliance and Transpulmonary Pressure in people with Complication of Ventilation Therapy and Postoperative Respiratory Complications, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative driving pressure (time frame: During abdominal surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.