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Ventilation Distribution After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03975348
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Lucia Comuzzi, University of Trieste

Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE April 15, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Change of global inhomogeneity index [ Time Frame: The data needed to calculate the index will be collected at minute 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 (i.e. at the end of every step of oxygen therapy). The values obtained will then all be compared each other. ]
This parameter, calculated from data collected with EIT, evaluates lung ventilation distribution. To calculate this index, the median value of regional impedance changes from ventilated regions within the tidal image has to be computed, then the sum of differences between the median and every pixel value needs to be calculated, and the result must be normalised by the sum of impedance values within the lung area. The minimum value of the index is 0 and corresponds to homogeneous ventilation, whereas the maximum value is 1 and corresponds to inhomogeneous ventilation (in this context likely due to atelectasis).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Change of Δ end expiratory lung impedance (ΔEELI) [ Time Frame: The data will be collected at minute 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 (i.e. at the end of every step of oxygen therapy). The values obtained will then all be compared each other. ]
    The parameter, measured with EIT, expresses deviations of the regional end-expiratory lung impedance in relation to the global tidal impedance variation. ΔEELI closely correlates with changes of end-expiratory lung volume of the EIT sensitivity region.
  • Change of tidal impedance variation [ Time Frame: The data will be collected at minute 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 (i.e. at the end of every step of oxygen therapy). The values obtained will then all be compared each other. ]
    This parameter, measured with EIT, corresponds to the difference between end-expiratory and end-inspiratory lung impedance and is related to tidal volume. It will be expressed in units, where one unit corresponds to the tidal impedance variation of the patient breathing with baseline conventional facemask.
  • Change of oxygenation [ Time Frame: The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other. ]
    Oxygen arterial partial pressure
  • Change of carbon dioxide [ Time Frame: The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other. ]
    Carbon dioxide arterial partial pressure
  • Change of pH [ Time Frame: The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other. ]
    Arterial pH
  • Change of respiratory rate [ Time Frame: The parameter will be collected at minute 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 (i.e. at the end of every step of oxygen therapy). The values obtained will then all be compared each other. ]
    Respiratory rate
  • Change of patient's comfort: modified Borg dyspnea scale [ Time Frame: The parameter will be collected at minute 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 (i.e. at the end of every step of oxygen therapy). The values obtained will then all be compared each other. ]
    Comfort related to the oxygen therapy will be evaluated with the modified Borg dyspnea scale (0: nothing at all, 0.5: very, very slight, 1: very slight, 2: slight, 3: moderate, 4: somewhat severe, 5: severe, 6, 7: very severe, 8, 9: very, very severe - almost maximal, 10: maximal)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ventilation Distribution After Bariatric Surgery
Official Title  ICMJE Evaluation of Ventilation Distribution After Bariatric Surgery - High Flow Nasal Cannulas Versus Continuous Positive Airway Pressure
Brief Summary Obese patients have an increased risk of developing post-operative respiratory complications due to their comorbidities. They have a restrictive ventilatory defect with reduction of lung volumes and expiratory flow limitation, higher airway resistance and collapsibility of the upper respiratory tract. These abnormalities are worsened by general anesthesia and opioid administration. It has been proved that oxygen therapy with HFNC (high flow nasal cannula) increases lung volumes through a continuous positive airway pressure (CPAP)-effect. This also improves gas exchange and decreases anatomical dead space. At the present time, CPAP represents the gold standard for the prevention of postoperative pulmonary complications. The purpose of this study is to evaluate lung ventilation, gas exchange and comfort with HFNC compared with CPAP during the post-operative period in patients who undergo laparoscopic bariatric surgery.
Detailed Description Immediately after bariatric surgery, patients will follow a pre-determined schedule of oxygen therapy with conventional facemask (from the beginning to minute 10), HFNC (with a flow of 40 L/min from minute 11 to 20, 60 L/min from minute 21to 30, 80 L/min from minute 31 to 40, 100 L/min from minute 41 to 50, 80 L/min from minute 51 to 60, 60 L/min from minute 61 to 70, 40 L/min from minute 71 to 80), conventional facemask again (washout, from minute 81 to 90) and CPAP (10 cmH2O, from minute 91 to 100). Lung ventilation will be evaluated with electrical impedance tomography (EIT), which measures thoracic impedance variations related to changes in lung aeration. At the end of each 10 minutes-period the following data will be collected: electrical impedance tomography data (to calculate the global inhomogeneity index, Δ end-expiratory lung impedance and tidal impedance variation), hemodynamic parameters, respiratory rate, SpO2, pain (numerical rating scale), level of sedation (Ramsey score) and patient comfort (modified Borg scale). An arterial blood gas will be collected at the end of the following steps: baseline facemask, HFNC 40 and 100 L/min, washout facemask and CPAP. Data about anesthetic/analgesic drugs and ventilation parameters will also be collected.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bariatric Surgery Candidate
  • Atelectasis, Postoperative Pulmonary
Intervention  ICMJE
  • Device: High flow nasal cannula
    High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
  • Device: Continuous positive airway pressure
    Positive airway pressure applied through a sealed face mask
  • Device: Facemask
    Oxygen therapy through a conventional facemask
Study Arms  ICMJE
  • Baseline conventional facemask
    The patients will receive oxygen therapy through conventional facemask for 10 minutes
    Intervention: Device: Facemask
  • Experimental: HFNC 40 L/min up
    The patients will receive oxygen/air mixture through high flow nasal cannula at incremental, then decremental flows, starting at 40 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 60 L/min up
    High flow nasal cannula at 60 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 80 L/min up
    High flow nasal cannula at 80 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 100 L/min
    High flow nasal cannula at 100 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 80 L/min down
    High flow nasal cannula at 80 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 60 L/min down
    High flow nasal cannula at 60 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Experimental: HFNC 40 L/min down
    High flow nasal cannula at 40 L/min for 10 minutes
    Intervention: Device: High flow nasal cannula
  • Washout conventional facemask
    Again, the patients will receive oxygen therapy through conventional facemask for 10 minutes, to reduce the influence of HFNC on CPAP therapy
    Intervention: Device: Facemask
  • Active Comparator: CPAP
    The patients will receive CPAP at 10 cmH2O for 10 minutes
    Intervention: Device: Continuous positive airway pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient's consent to the trial
  • Candidate to laparoscopic bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass)
  • BMI 35-50 kg/m2
  • ASA class 1-3

Exclusion Criteria:

  • Obesity hypoventilation syndrome
  • Contraindication to EIT (e.g. implantable cardioverter-defibrillator)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975348
Other Study ID Numbers  ICMJE 123/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lucia Comuzzi, University of Trieste
Study Sponsor  ICMJE University of Trieste
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucia Comuzzi Azienda Sanitaria Universitaria Integrata di Trieste
PRS Account University of Trieste
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP