Effects of Mechanical Ventilation Guided by Transpulmonary Pressure on Gas Exchange During Robotic Surgery: a Pilot Study

NCT03153592 | Completed

• 1 other identifier: CE 62/17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Artificial Respiration; Surgery; Atelectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intraoperative respiratory mechanics indexes changes

  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.

• Number of lung recruitment maneuvers

  During the whole surgical procedure

• Type of perioperative complications

  within the following 30 days after surgery

• Rate of perioperative complications

  within the following 30 days after surgery

Study Arms (2)

conventional ventilation strategy

ACTIVE COMPARATOR

13 patients will undergo volume controlled ventilation set with a tidal volume between 6-8 ml/kg of ideal body weight, positive end-expiratory pressure and fraction of inspired oxygen set to obtain a peripheral saturation in oxygen equal or greater than 94% and a plateau pressure \<28 cmH2O.

Procedure: Conventional ventilation strategy

transpulmonary pressure strategy

EXPERIMENTAL

13 patients will undergo volume controlled ventilation set with a tidal volume at 6-8 ml/kg of ideal body weight, and with a inspiratory transpulmonary pressure less than 20 cmH2O and an expiratory transpulmonary pressure and inspired oxygen set accordingly to predefined criteria.

Procedure: Transpulmonary pressure driven ventilation strategy

Interventions

Transpulmonary pressure driven ventilation strategy PROCEDURE

Patients will receive volume controlled ventilation set with a tidal volume at 6-8 ml/kg of ideal body weight, an inspiratory transpulmonary pressure less than 20 cmH2O, and an expiratory transpulmonary pressure (PLexp) equal or greater than 0. At PLexp increasing from 0 up to 10 cmH2O, inspired fraction of oxygen would also be increased from 40% to 100%. Respiratory rate will be set to obtain an arterial partial pressure of carbon dioxide between 35 and 45 mmHg and to ensure a physiological pH. Whenever the clinician will deem it appropriate, an alveolar recruitment maneuver as previously described

transpulmonary pressure strategy

Conventional ventilation strategy PROCEDURE

13 patients will undergo volume controlled ventilation set with a tidal volume between 6-8 ml/kg of ideal body weight, positive end-expiratory pressure and fraction of inspired oxygen set to obtain a peripheral saturation in oxygen equal or greater than 94% and a plateau pressure \<28 cmH2O Respiratory rate will be set to obtain an arterial partial pressure of carbon dioxide between 35 and 45 mmHg and in any case to ensure a physiological pH. In addition, whenever the clinician will deem it appropriate, an alveolar recruitment maneuver will be performed as previously described

conventional ventilation strategy

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) score I - II
• Patients requiring elective robotic gynecological-abdominal surgery

You may not qualify if:

• \- Contraindications to the positioning of a naso-gastric tube

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

AOU Maggiore della Carita

Novara, 28100, Italy

Location

Related Publications (8)

• 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. doi: 10.1016/j.bpa.2010.02.002.

  PMID: 20608559 BACKGROUND

• Strang CM, Hachenberg T, Freden 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.

  PMID: 19443420 BACKGROUND

• 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. doi: 10.1097/00000539-200012000-00041.

  PMID: 11094011 BACKGROUND

• 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.

  PMID: 18451319 BACKGROUND

• 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. doi: 10.1097/00000542-199911000-00011.

  PMID: 10551570 BACKGROUND

• 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.

  PMID: 21068660 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

• Cammarota G, Lauro G, Sguazzotti I, Mariano I, Perucca R, Messina A, Zanoni M, Garofalo E, Bruni A, Della Corte F, Navalesi P, Bignami E, Vaschetto R, Mojoli F. Esophageal Pressure Versus Gas Exchange to Set PEEP During Intraoperative Ventilation. Respir Care. 2020 May;65(5):625-635. doi: 10.4187/respcare.07238.

  PMID: 32345760 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know the arm of assignment. Care providers and investigators will know the arm, making the masking not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in staff of the ICU

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: September 14, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)