ObesityNCT05709041
Effect of Transpulmonary Pressure Guided Ventilation on Intraoperative Right Heart Function
A study testing Individualized lung-protective ventilation and Standard lung-protective ventilation in people with Obesity and Surgery, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Surgery, Anesthesia
- What is being tested?
- Individualized lung-protective ventilation and Standard lung-protective ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 15 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robotic-assisted laparoscopic surgery at University of Vermont Medical Center in Trendelenburg position
- Age ≥ 18 years
- Signed consent form
Who cannot join
- Inability to sign consent form
- Inability to speak English
- Emergent surgery
- Current smoker
- Smoking history ≥20 pack years
- Esophageal pathology: Strictures, varices, history of esophageal dilatation or surgery
Show all 9Show fewer
- Intrinsic lung disease (e.g. asthma, COPD, emphysema, interstitial lung disease, lung cancer)
- Impaired cardiac function (e.g. decreased ejection fraction, wall motion abnormalities, or cardiomyopathy).
- Any other co-morbid condition that, in the opinion of the study investigators, may interfere with study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vemont Medical Center
Burlington, Vermont, 05401
About this study
The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart.
In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings.
Read more
Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs.
For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded.
For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery.
A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed.
Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.
Read the detailed description
This study builds on the concepts and techniques used successfully in the study "Changes in Transpulmonary Pressures During Varying Surgical Conditions," CHRMS 18-0048, which demonstrated that obese patients have significantly worse lung mechanics than lean patients during robotic-assisted laparoscopic surgery. (This is a type of minimally invasive surgery in which the patient is tilted head downward on the operating table (the Trendelenburg position), and the abdomen is inflated with carbon dioxide; both of these steps allow more room in the abdomen for surgical instruments, and allow a better field of vision for the surgeon). In that study, which is ongoing, we use a balloon catheter in the patient's esophagus as a way to measure the pressures experienced by the lung: With each breath, the lungs push on the esophagus; the balloon catheter is attached to an external pressure transducer, which allows us to record the lung pressures during surgery.
During surgery with general anesthesia (and sometimes in the ICU), the patient's breathing is controlled by a mechanical ventilator. Under physiologically stressful conditions, such as acute respiratory distress syndrome (ARDS), or mechanically stressful conditions, such as surgery in Trendelenburg position, setting the ventilator can become a balancing act between what is safe for the lungs and the effects on other organ systems, such as the heart.
In this study, we hypothesize that obesity in combination with inflation of the abdomen and steep Trendelenburg positioning are associated with elevated right heart strain, and that the use of lung pressure measurements to guide ventilation may ameliorate the increased strain. We will conduct an ultrasound exam of the heart and lungs at three points during the surgical procedure: The first will occur after the patient is anesthetized, but before the surgical incision has been made; the second will be while the patient is in steep Trendelenburg position; and the third will take place near the end of surgery, just before desufflation of the abdomen. The ultrasound exam is done by inserting a probe through the patient's mouth into their esophagus and stomach, because that provides a close view of the heart and lungs; this type of exam is typically done on cardiac surgery patients.
This study is a randomized controlled trial of ventilation in lean and obese subjects undergoing robotic abdominal surgery. Subjects will be randomized to receive either standard lung-protective ventilation or transpulmonary pressure-guided ventilation using the esophageal balloon catheter.
Objective 1: To determine the effect of obesity and surgical conditions on right heart function. We will compare ultrasound measurements of the right ventricle of the heart between lean and obese subjects immediately after intubation, while in steep Trendelenburg position, and again just before desufflation of the abdomen.
Objective 2: To determine if intraoperative transpulmonary pressure-guided ventilation alters right heart function. We will compare ultrasound measurements of the right ventricle of the heart between subjects randomized to standard ventilation or transpulmonary pressure-guided ventilation.
Procedures: In the preoperative area, measurement of the patient's waist size and weight. Once in the operating room, after general anesthesia is induced, the first ultrasound exam will be conducted. The ultrasound probe will be inserted into the esophagus and stomach to examine the heart and lungs, and images will be saved. Each exam will take 5-10 minutes, and will not extend the length of your surgery. A plastic tooth guard will be used to protect the patient's teeth. The ultrasound will be removed after the exam is over.
Next, a small balloon catheter (smaller in diameter than a pencil lead) will be placed in the esophagus. We will record the pressures and gas flows from the ventilator and in the balloon catheter for the entire surgery.
Patients will be randomly assigned (like flipping a coin) to receive either standard or individualized ventilation. If you assigned to standard lung-protective ventilation, we will use national anesthesiology guidelines to set and maintain the ventilator during surgery. If assigned to individualized ventilation, we will use the same national guidelines to set the ventilator but then adjust the pressures at the end of each breath using the measurements from the balloon catheter. We will make this adjustment every 30 minutes during the surgery.
The second ultrasound exam will be performed after the patient is tilted into the Trendelenburg position. At the end of surgery before the third ultrasound, we will remove the catheter the esophagus, and then perform the third ultrasound exam.
- Being tested
- Individualized lung-protective ventilation, Standard lung-protective ventilation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized lung-protective ventilationOther
Also called Ventilator settings during general anesthesia
Lung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry.
The ventilator will be set to volume-controlled ventilation with a tidal volume of 6 mL/kg of ideal body weight, inspired oxygen fraction of 30%, inspiratory pause of 30%, inspiration-to-expiration ratio of 1:2, PEEP of 5 cm H2O, and flow of 3 L/min). The respiratory rate will be set to 12 breaths/min in the beginning then adjusted (within 10-20 breaths/ min) to maintain EtCO2 between 35 to 45 mm Hg.
The set PEEP will be then increased by 2 cm H2O every 2 minutes (up to a max of 30 cm H2O) to identify and maintain the lowest driving pressure, maximum compliance, and positive TPP. These steps will be performed every 30 minutes after intubation, and after instillation of the pneumoperitoneum, and after steep Trendelenburg positioning. These individualized PEEP settings will be maintained until the pneumoperitoneum is released.
Standard lung-protective ventilationOther
Also called Ventilator settings during general anesthesia
Ventilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard lung protective ventilator settings | Active comparator | Ventilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure. Receives: Other: Standard lung-protective ventilation |
| Individualized lung protective ventilator settings | Experimental | Lung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry. Receives: Other: Individualized lung-protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether intraoperative transpulmonary pressure (TPP)-guided ventilation alters right heart function.
TEE measurements of right ventricular function will be compared between subjects randomized to standard ventilation or TPP-guided ventilation.
Measured: TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.
Secondary outcomes (1)
To determine the effect of obesity and surgical conditions on right heart function.
Transesophageal echocardiographic (TEE) measurements of right ventricular function will be compared between lean and obese subjects, and between surgical stages.
Measured: TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start30 Jan 2023 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William G Tharp, University of Vermont Medical Center
- Investigators
- William G Tharp, MD PhD, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709041
- Sponsor's protocol ID
- STUDY00002103
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sundar S, Novack V, Jervis K, Bender SP, Lerner A, Panzica P, Mahmood F, Malhotra A, Talmor D. Influence of low tidal volume ventilation on time to extubation in cardiac surgical patients. Anesthesiology. 2011 May;114(5):1102-10. doi: 10.1097/ALN.0b013e318215e254.
PubMed 21430518Chaney MA, Nikolov MP, Blakeman BP, Bakhos M. Protective ventilation attenuates postoperative pulmonary dysfunction in patients undergoing cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2000 Oct;14(5):514-8. doi: 10.1053/jcan.2000.9487.
PubMed 11052430Lellouche F, Dionne S, Simard S, Bussieres J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012 May;116(5):1072-82. doi: 10.1097/ALN.0b013e3182522df5.
PubMed 22450472Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.
PubMed 16809989Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
PubMed 24894577Eichler L, Truskowska K, Dupree A, Busch P, Goetz AE, Zollner C. Intraoperative Ventilation of Morbidly Obese Patients Guided by Transpulmonary Pressure. Obes Surg. 2018 Jan;28(1):122-129. doi: 10.1007/s11695-017-2794-3.
PubMed 28707173Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Grieco DL, Anzellotti GM, Russo A, Bongiovanni F, Costantini B, D'Indinosante M, Varone F, Cavallaro F, Tortorella L, Polidori L, Romano B, Gallotta V, Dell'Anna AM, Sollazzi L, Scambia G, Conti G, Antonelli M. Airway Closure during Surgical Pneumoperitoneum in Obese Patients. Anesthesiology. 2019 Jul;131(1):58-73. doi: 10.1097/ALN.0000000000002662.
PubMed 30882475Tharp WG, Murphy S, Breidenstein MW, Love C, Booms A, Rafferty MN, Friend AF, Perrapato S, Ahern TP, Dixon AE, Bates JHT, Bender SP. Body Habitus and Dynamic Surgical Conditions Independently Impair Pulmonary Mechanics during Robotic-assisted Laparoscopic Surgery. Anesthesiology. 2020 Oct 1;133(4):750-763. doi: 10.1097/ALN.0000000000003442.
PubMed 32675698
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transpulmonary Pressure Guided Ventilation on Intraoperative Right Heart Function
- ClinicalTrials.gov ID
- NCT05709041
- Acronym / sponsor ID
- STUDY00002103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- 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 clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart.
In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings.
Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs.
For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded.
For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery.
A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed.
Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.
Detailed description
This study builds on the concepts and techniques used successfully in the study "Changes in Transpulmonary Pressures During Varying Surgical Conditions," CHRMS 18-0048, which demonstrated that obese patients have significantly worse lung mechanics than lean patients during robotic-assisted laparoscopic surgery. (This is a type of minimally invasive surgery in which the patient is tilted head downward on the operating table (the Trendelenburg position), and the abdomen is inflated with carbon dioxide; both of these steps allow more room in the abdomen for surgical instruments, and allow a better field of vision for the surgeon). In that study, which is ongoing, we use a balloon catheter in the patient's esophagus as a way to measure the pressures experienced by the lung: With each breath, the lungs push on the esophagus; the balloon catheter is attached to an external pressure transducer, which allows us to record the lung pressures during surgery.
During surgery with general anesthesia (and sometimes in the ICU), the patient's breathing is controlled by a mechanical ventilator. Under physiologically stressful conditions, such as acute respiratory distress syndrome (ARDS), or mechanically stressful conditions, such as surgery in Trendelenburg position, setting the ventilator can become a balancing act between what is safe for the lungs and the effects on other organ systems, such as the heart.
In this study, we hypothesize that obesity in combination with inflation of the abdomen and steep Trendelenburg positioning are associated with elevated right heart strain, and that the use of lung pressure measurements to guide ventilation may ameliorate the increased strain. We will conduct an ultrasound exam of the heart and lungs at three points during the surgical procedure: The first will occur after the patient is anesthetized, but before the surgical incision has been made; the second will be while the patient is in steep Trendelenburg position; and the third will take place near the end of surgery, just before desufflation of the abdomen. The ultrasound exam is done by inserting a probe through the patient's mouth into their esophagus and stomach, because that provides a close view of the heart and lungs; this type of exam is typically done on cardiac surgery patients.
This study is a randomized controlled trial of ventilation in lean and obese subjects undergoing robotic abdominal surgery. Subjects will be randomized to receive either standard lung-protective ventilation or transpulmonary pressure-guided ventilation using the esophageal balloon catheter.
Objective 1: To determine the effect of obesity and surgical conditions on right heart function. We will compare ultrasound measurements of the right ventricle of the heart between lean and obese subjects immediately after intubation, while in steep Trendelenburg position, and again just before desufflation of the abdomen.
Objective 2: To determine if intraoperative transpulmonary pressure-guided ventilation alters right heart function. We will compare ultrasound measurements of the right ventricle of the heart between subjects randomized to standard ventilation or transpulmonary pressure-guided ventilation.
Procedures: In the preoperative area, measurement of the patient's waist size and weight. Once in the operating room, after general anesthesia is induced, the first ultrasound exam will be conducted. The ultrasound probe will be inserted into the esophagus and stomach to examine the heart and lungs, and images will be saved. Each exam will take 5-10 minutes, and will not extend the length of your surgery. A plastic tooth guard will be used to protect the patient's teeth. The ultrasound will be removed after the exam is over.
Next, a small balloon catheter (smaller in diameter than a pencil lead) will be placed in the esophagus. We will record the pressures and gas flows from the ventilator and in the balloon catheter for the entire surgery.
Patients will be randomly assigned (like flipping a coin) to receive either standard or individualized ventilation. If you assigned to standard lung-protective ventilation, we will use national anesthesiology guidelines to set and maintain the ventilator during surgery. If assigned to individualized ventilation, we will use the same national guidelines to set the ventilator but then adjust the pressures at the end of each breath using the measurements from the balloon catheter. We will make this adjustment every 30 minutes during the surgery.
The second ultrasound exam will be performed after the patient is tilted into the Trendelenburg position. At the end of surgery before the third ultrasound, we will remove the catheter the esophagus, and then perform the third ultrasound exam.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard lung protective ventilator settings | Active comparator | Other: Standard lung-protective ventilationVentilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure. |
| Individualized lung protective ventilator settings | Experimental | Other: Individualized lung-protective ventilationLung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing robotic-assisted laparoscopic surgery at University of Vermont Medical Center in Trendelenburg position
- Age ≥ 18 years
- Signed consent form
Key exclusion criteria (9 listed)
- Inability to sign consent form
- Inability to speak English
- Emergent surgery
- Current smoker
- Smoking history ≥20 pack years
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 |
|---|---|---|
| Individualized lung-protective ventilationAlso: Ventilator settings during general anesthesiaLung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry. The ventilator will be set to volume-controlled ventilation with a tidal volume of 6 mL/kg of ideal body weight, inspired oxygen fraction of 30%, inspiratory pause of 30%, inspiration-to-expiration ratio of 1:2, PEEP of 5 cm H2O, and flow of 3 L/min). The respiratory rate will be set to 12 breaths/min in the beginning then adjusted (within 10-20 breaths/ min) to maintain EtCO2 between 35 to 45 mm Hg. The set PEEP will be then increased by 2 cm H2O every 2 minutes (up to a max of 30 cm H2O) to identify and maintain the lowest driving pressure, maximum compliance, and positive TPP. These steps will be performed every 30 minutes after intubation, and after instillation of the pneumoperitoneum, and after steep Trendelenburg positioning. These individualized PEEP settings will be maintained until the pneumoperitoneum is released. | Other | Individualized lung protective ventilator settings |
| Standard lung-protective ventilationAlso: Ventilator settings during general anesthesiaVentilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure. | Other | Standard lung protective ventilator settings |
Primary outcome
To determine whether intraoperative transpulmonary pressure (TPP)-guided ventilation alters right heart function.
Time frame: TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.
TEE measurements of right ventricular function will be compared between subjects randomized to standard ventilation or TPP-guided ventilation.
1 secondary outcome
To determine the effect of obesity and surgical conditions on right heart function.
Time frame: TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 21430518Sundar S, Novack V, Jervis K, Bender SP, Lerner A, Panzica P, Mahmood F, Malhotra A, Talmor D. Influence of low tidal volume ventilation on time to extubation in cardiac surgical patients. Anesthesiology. 2011 May;114(5):1102-10. doi: 10.1097/ALN.0b013e318215e254.
- Background: PubMed 11052430Chaney MA, Nikolov MP, Blakeman BP, Bakhos M. Protective ventilation attenuates postoperative pulmonary dysfunction in patients undergoing cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2000 Oct;14(5):514-8. doi: 10.1053/jcan.2000.9487.
- Background: PubMed 22450472Lellouche F, Dionne S, Simard S, Bussieres J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012 May;116(5):1072-82. doi: 10.1097/ALN.0b013e3182522df5.
- Background: PubMed 16809989Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.
- Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- Background: PubMed 24894577PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
- Background: PubMed 28707173Eichler L, Truskowska K, Dupree A, Busch P, Goetz AE, Zollner C. Intraoperative Ventilation of Morbidly Obese Patients Guided by Transpulmonary Pressure. Obes Surg. 2018 Jan;28(1):122-129. doi: 10.1007/s11695-017-2794-3.
- Background: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Background: PubMed 30882475Grieco DL, Anzellotti GM, Russo A, Bongiovanni F, Costantini B, D'Indinosante M, Varone F, Cavallaro F, Tortorella L, Polidori L, Romano B, Gallotta V, Dell'Anna AM, Sollazzi L, Scambia G, Conti G, Antonelli M. Airway Closure during Surgical Pneumoperitoneum in Obese Patients. Anesthesiology. 2019 Jul;131(1):58-73. doi: 10.1097/ALN.0000000000002662.
- Background: PubMed 32675698Tharp WG, Murphy S, Breidenstein MW, Love C, Booms A, Rafferty MN, Friend AF, Perrapato S, Ahern TP, Dixon AE, Bates JHT, Bender SP. Body Habitus and Dynamic Surgical Conditions Independently Impair Pulmonary Mechanics during Robotic-assisted Laparoscopic Surgery. Anesthesiology. 2020 Oct 1;133(4):750-763. doi: 10.1097/ALN.0000000000003442.
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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.
William G Tharp, MD PhD principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized lung-protective ventilation and Standard lung-protective ventilation in people with Obesity and Surgery, run by University of Vermont Medical Center 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 9 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Friend, MS (802-847-4259, alexander.friend@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether intraoperative transpulmonary pressure (TPP)-guided ventilation alters right heart function. (time frame: TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.). 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 NCT05709041, which also lists 10 linked publications.
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 1 Feb 2023.