Effect of Transpulmonary Pressure Guided Ventilation on Intraoperative Right Heart Function

NCT05709041 | Not Yet Recruiting

• 1 other identifier: STUDY00002103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Surgery; Anesthesia; Echocardiography, Transesophageal; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  TEE studies will be performed immediately after intubation, while in steep Trendelenburg position, and just before desufflation of the abdomen.

Study Arms (2)

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.

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.

Other: Individualized lung-protective ventilation

Interventions

Individualized lung-protective ventilation OTHER

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.

Also known as: Ventilator settings during general anesthesia

Individualized lung protective ventilator settings

Standard lung-protective ventilation OTHER

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.

Also known as: Ventilator settings during general anesthesia

Standard lung protective ventilator settings

Eligibility Criteria

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

You may qualify if:

• Patients undergoing robotic-assisted laparoscopic surgery at University of Vermont Medical Center in Trendelenburg position
• Age ≥ 18 years
• Signed consent form

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vemont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (10)

• 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.

  PMID: 21430518 BACKGROUND

• Chaney 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.

  PMID: 11052430 BACKGROUND

• Lellouche 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.

  PMID: 22450472 BACKGROUND

• Fernandez-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.

  PMID: 16809989 BACKGROUND

• Futier 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.

  PMID: 23902482 BACKGROUND

• PROVE 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.

  PMID: 24894577 BACKGROUND

• Eichler 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.

  PMID: 28707173 BACKGROUND

• Talmor 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.

  PMID: 19001507 BACKGROUND

• Grieco 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.

  PMID: 30882475 BACKGROUND

• Tharp 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.

  PMID: 32675698 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William G Tharp, MD PhD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Friend, MS

CONTACT

802-847-4259; alexander.friend@uvmhealth.org

William G Tharp, MD PhD

CONTACT

802-847-2415; william.tharp@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 30, 2023
• Primary Completion: October 15, 2025
• Study Completion: March 15, 2026
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)