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Trial record 4 of 5 for:    20608559 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03153592
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita

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).


Condition or disease Intervention/treatment Phase
Artificial Respiration Surgery Atelectasis Procedure: Transpulmonary pressure driven ventilation strategy Procedure: Conventional ventilation strategy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patients will not know the arm of assignment. Care providers and investigators will know the arm, making the masking not possible.
Primary Purpose: Supportive Care
Official Title: Effects of Mechanical Ventilation Guided by Transpulmonary Pressure on Gas Exchange During Robotic Surgery
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : September 30, 2018

Arm Intervention/treatment
Active Comparator: conventional ventilation strategy
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
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

Experimental: transpulmonary pressure strategy
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
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




Primary Outcome Measures :
  1. Oxygenation Changes [ Time Frame: 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. ]
    Ratio between the arterial partial pressure (PaO2) and inspired fraction (FiO2) of oxygen (PaO2/FiO2)


Secondary Outcome Measures :
  1. Intraoperative respiratory mechanics indexes changes [ Time Frame: 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. ]
    Airway pressure, flow, esophageal and transpulmonary pressures

  2. Number of lung recruitment maneuvers [ Time Frame: During the whole surgical procedure ]
    The number of recruitment maneuvers required during the surgery will be recorded

  3. Type of perioperative complications [ Time Frame: within the following 30 days after surgery ]
    postoperative hypoxemia, presence of lung atelectasis, occurrence of pneumonia, sepsis, severe sepsis or septic shock

  4. Rate of perioperative complications [ Time Frame: within the following 30 days after surgery ]
    Number of perioperative complication occurred during the hospital length of stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153592


Contacts
Contact: Gianmaria Cammarota, MD, PhD 003903213733380 gmcamma@gmail.com

Locations
Italy
AOU Maggiore della Carita Recruiting
Novara, Italy, 28100
Contact: Gianmaria Cammarota, MD,PHD    +390321373406    gmcamma@gmail.com   
Contact: Gianmaria Cammarota, MD,PHD    +3903213733406    gmcamma@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita

Publications:

Responsible Party: Gianmaria Cammarota, Physician in staff of the ICU, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03153592     History of Changes
Other Study ID Numbers: CE 62/17
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases