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Effects on Respiratory Mechanics of Two Different Ventilation Strategies During Robotic-Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT03335449
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
dott giorgia spinazzola, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:

This Randomized controlled clinical study, entitled "Effects on Respiratory mechanics of two different ventilation strategies during Robotic- Gynecological surgery", is an original paper. The study was performed in Rome, Italy, from September 2014 to September 2015.

Nowadays several studies evaluated the effects of "open lung strategy" and the positive effect of Recruitment Maneuvers and Positive End Expiratory Pressure (PEEP) application during general anesthesia, especially during open abdominal surgery and in elderly patients.

This is the first study aimed at evaluating two different ventilation strategies in healthy respiratory women undergoing Robotic surgery. In particular, the investigators evaluated the effects of protective ventilation strategy on respiratory mechanics, gas exchange and post-operative respiratory complications compared to standard ventilation.


Condition or disease Intervention/treatment Phase
Respiratory Mechanics Mechanical Ventilation Complication Other: Protective ventilation group Not Applicable

Detailed Description:

The ventilation protocol consisted in volume-controlled mechanical ventilation through Ventilator, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (end-tidal carbon dioxide partial pressure between 30 and 40 mmHg). The were randomly assigned to Standard (SV) or Protective (PV) group.

participants in the SV group received a Tidal Volume (Vt) of 10 ml/kg of Ideal Body Weight (IBW) and a PEEP of 5 cmH2O, the participants in the PV group a Vt of 6 ml/kg of IBW and a PEEP of 8-10 cmH2O, associated to recruitment maneuvers (RMs).

RMs were performed only in hemodynamic stable conditions and at pre-set moments: after the induction of anesthesia, after any disconnection from the mechanical ventilator, each hour during the surgical procedures and immediately before extubation. RMs were performed in Pressure Control mode as follows: the limit of peak inspiratory pressure was set at 45 cmH2O and the pressure control was set at 30 cmH2O, therefore three consecutive thirty seconds lasting inspiratory pauses were performed. At the end of RMs, respiratory rate, inspiratory to expiratory ratio, inspiratory pause, and Vt were set back at values preceding the RMs.

Air Flow (V') was measured with a heated pneumotachograph, inserted between the Y-piece of the ventilator circuit and the endotracheal tube. The pneumotachograph was linear over the experimental range of flow. Volume was obtained by numerical integration of the flow signal. Airway pressure (Paw) was measured proximal to the endotracheal tube with a pressure transducer with a differential pressure of ± 100 cm H2O. The end-inspiratory and end-expiratory occlusions were performed through specific maneuver of ventilator.

Following end-inspiratory occlusion there is an immediate drop of the airway pressure from a maximal value (Pmax) to airway pressure at zero flow (P1), followed by a further decrease to plateau pressure (P2). The plateau pressure usually arrived within 3 seconds. Therefore, airway pressure 3 seconds after occlusion was taken as the static end-inspiratory elastic recoil pressure (P2) of the respiratory system. The use of the interrupter method for the measurement of respiratory mechanics allows possible quantification of the airway and viscoelastic properties of the respiratory system. The difference between Pmax and P1 divided by flow provides major information about minimal airway resistance (Rmin), while the difference between P1 and P2 (ΔP) divided by flow stands for viscoelastic resistance or Pendelluft effect of the respiratory system (ΔR). Maximal respiratory resistance (Rmax) is the sum of Rmin and ΔR. The inspiratory volume divided by P2- Total PEEP yields respiratory system compliance. Mechanical respiratory measurements and arterial blood gases were performed immediately after intubation, after pneumoperitoneum (AP), every hour during the procedure and before extubation (Ext). A further arterial blood gas sample was analyzed 1 hour after extubation.

The day after the surgical procedure, clinical patient examination and chest x ray were performed, in order to detect eventual pulmonary adverse events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Effects on Respiratory Mechanics of Two Different Ventilation Strategies During Robotic-Gynecological Surgery
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : December 30, 2015

Arm Intervention/treatment
Experimental: Protective ventilation group
Protective ventilation (PV group) (Vt 6 ml/Kg of ideal body weight, PEEP 8-10 cmH 2 O and repeated recruitment maneuvers.
Other: Protective ventilation group
Application of a protective ventilation strategy in order to improve gas exchange and respiratory mechanics during Robotic surgery in deep Trendelenburg position.
Other Name: Low tidal volume, high PEEP and recruitment maneuvers

No Intervention: Standard ventilation group
Standard ventilation (SV group) (Tidal Volume, Vt 10 ml/Kg of ideal body weight, Positive End Expiratory Pressure, PEEP 5 cmH 2 O, no recruitment maneuvers)



Primary Outcome Measures :
  1. Respiratory Compliance [ Time Frame: One year ]
    inspiratory Volume/Plateau Pressure-PEEP (ml/cmH2O)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Gynecological cancer elegible for laparoscopic surgery

Exclusion Criteria:

  • Respiratory disease
  • Obesity
  Study Documents (Full-Text)

Documents provided by dott giorgia spinazzola, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Publications:

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Responsible Party: dott giorgia spinazzola, Physician, specialist in Anesthesia and Intensive Care Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03335449    
Other Study ID Numbers: 10398/14
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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