Surgery Clinical Trial
— VetrapoOfficial title:
Effects of Mechanical Ventilation Guided by Transpulmonary Pressure on Gas Exchange During Robotic Surgery
Verified date | July 2019 |
Source | Azienda Ospedaliero Universitaria Maggiore della Carita |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laparoscopy and robotic techniques are widespread procedures for pelvic gynecologic, urologic
and abdominal surgery often performed in Trendelenburg position, with the application of
pneumoperitoneum by inflating carbon dioxide. The rise in abdominal pressure following
pneumoperitoneum and the head down body position have been shown to impair the respiratory
function during the procedure, mainly inducing atelectasis formation in the dependent lung
regions, worsening stress and strain of the alveolar structure.
The application of a ventilator strategy providing positive end-expiratory pressure (PEEP)
has been shown to reduce the diaphragm cranial shift, increasing functional residual capacity
and decreasing respiratory system elastance. Furthermore, the application of recruiting
maneuver followed by the subsequent application of PEEP improved oxygenation. These results
are in accordance with finding by Talmor et al, evaluating the effect of a mechanical
ventilation guided by esophageal pressure in acute lung injury patients.
However a comparison between an esophageal pressure piloted mechanical ventilation and a
conventional low tidal ventilator strategy with adjunct of PEEP and recruitment maneuvers
according to clinical judgment has never been investigated in patients undergoing robotic
gynecologic, abdominal or urologic surgery. The investigators aim to compare the conventional
ventilation strategy (i.e. with application of PEEP and recruitment manoeuvre) with a
ventilation driven by transpulmonary pressure assessed through an esophageal catheter, in
patients undergoing to robotic surgery, with respect to oxygenation, expressed in terms of
arterial oxygen tension - inspired oxygen fraction ratio (PaO2/FiO2) (primary endpoint),
intraoperative respiratory mechanics indexes, number of lung recruitment maneuvers, rate and
type of perioperative complications until hospital discharge (additional endpoint).
Status | Completed |
Enrollment | 28 |
Est. completion date | May 30, 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists (ASA) score I - II - Patients requiring elective robotic gynecological-abdominal surgery Exclusion Criteria: - Contraindications to the positioning of a naso-gastric tube |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Maggiore della Carita | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1. — View Citation
Futier E, Constantin JM, Pelosi P, Chanques G, Kwiatkoskwi F, Jaber S, Bazin JE. Intraoperative recruitment maneuver reverses detrimental pneumoperitoneum-induced respiratory effects in healthy weight and obese patients undergoing laparoscopy. Anesthesiology. 2010 Dec;113(6):1310-9. doi: 10.1097/ALN.0b013e3181fc640a. — View Citation
Pelosi P, Ravagnan I, Giurati G, Panigada M, Bottino N, Tredici S, Eccher G, Gattinoni L. Positive end-expiratory pressure improves respiratory function in obese but not in normal subjects during anesthesia and paralysis. Anesthesiology. 1999 Nov;91(5):1221-31. — View Citation
Perilli V, Sollazzi L, Bozza P, Modesti C, Chierichini A, Tacchino RM, Ranieri R. The effects of the reverse trendelenburg position on respiratory mechanics and blood gases in morbidly obese patients during bariatric surgery. Anesth Analg. 2000 Dec;91(6):1520-5. — View Citation
Strang CM, Hachenberg T, Fredén F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13. — View Citation
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. — View Citation
Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygenation Changes | Ratio between the arterial partial pressure (PaO2) and inspired fraction (FiO2) of oxygen (PaO2/FiO2) | Soon after anesthesia induction (step 1), after 45 min from step 1 (pneumoperitoneum, trendelemburg, recruitment maneuver application-step 2),after 20min from randomization (step 3), every 60 min during surgery and at its end, after 1 hour from recovery. | |
Secondary | Intraoperative respiratory mechanics indexes changes | Airway pressure, flow, esophageal and transpulmonary pressures | Soon after anesthesia induction (step 1), after 45 min from step 1 (pneumoperitoneum, trendelemburg, recruitment maneuver application-step 2),after 20min from randomization (step 3), every 60 min during surgery and at its end, after 1 hour from recovery. | |
Secondary | Number of lung recruitment maneuvers | The number of recruitment maneuvers required during the surgery will be recorded | During the whole surgical procedure | |
Secondary | Type of perioperative complications | postoperative hypoxemia, presence of lung atelectasis, occurrence of pneumonia, sepsis, severe sepsis or septic shock | within the following 30 days after surgery | |
Secondary | Rate of perioperative complications | Number of perioperative complication occurred during the hospital length of stay | within the following 30 days after surgery |
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