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Ventilation Distribution After Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Atelectasis, Postoperative Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High flow nasal cannula
Continuous positive airway pressure
Facemask
Sponsored by
University of Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring High flow nasal cannula, Bariatric surgery, Postoperative atelectasis, Electrical impedance tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Azienda Sanitaria Universitaria Integrata di Trieste

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Active Comparator

Arm Label

Baseline conventional facemask

HFNC 40 L/min up

HFNC 60 L/min up

HFNC 80 L/min up

HFNC 100 L/min

HFNC 80 L/min down

HFNC 60 L/min down

HFNC 40 L/min down

Washout conventional facemask

CPAP

Arm Description

The patients will receive oxygen therapy through conventional facemask for 10 minutes

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

High flow nasal cannula at 60 L/min for 10 minutes

High flow nasal cannula at 80 L/min for 10 minutes

High flow nasal cannula at 100 L/min for 10 minutes

High flow nasal cannula at 80 L/min for 10 minutes

High flow nasal cannula at 60 L/min for 10 minutes

High flow nasal cannula at 40 L/min for 10 minutes

Again, the patients will receive oxygen therapy through conventional facemask for 10 minutes, to reduce the influence of HFNC on CPAP therapy

The patients will receive CPAP at 10 cmH2O for 10 minutes

Outcomes

Primary Outcome Measures

Change of global inhomogeneity index
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).

Secondary Outcome Measures

Change of Δ end expiratory lung impedance (ΔEELI)
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
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
Oxygen arterial partial pressure
Change of carbon dioxide
Carbon dioxide arterial partial pressure
Change of pH
Arterial pH
Change of respiratory rate
Respiratory rate
Change of patient's comfort: modified Borg dyspnea scale
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)

Full Information

First Posted
May 3, 2019
Last Updated
July 29, 2020
Sponsor
University of Trieste
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1. Study Identification

Unique Protocol Identification Number
NCT03975348
Brief Title
Ventilation Distribution After Bariatric Surgery
Official Title
Evaluation of Ventilation Distribution After Bariatric Surgery - High Flow Nasal Cannulas Versus Continuous Positive Airway Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trieste

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Atelectasis, Postoperative Pulmonary
Keywords
High flow nasal cannula, Bariatric surgery, Postoperative atelectasis, Electrical impedance tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline conventional facemask
Arm Type
Other
Arm Description
The patients will receive oxygen therapy through conventional facemask for 10 minutes
Arm Title
HFNC 40 L/min up
Arm Type
Experimental
Arm Description
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
Arm Title
HFNC 60 L/min up
Arm Type
Experimental
Arm Description
High flow nasal cannula at 60 L/min for 10 minutes
Arm Title
HFNC 80 L/min up
Arm Type
Experimental
Arm Description
High flow nasal cannula at 80 L/min for 10 minutes
Arm Title
HFNC 100 L/min
Arm Type
Experimental
Arm Description
High flow nasal cannula at 100 L/min for 10 minutes
Arm Title
HFNC 80 L/min down
Arm Type
Experimental
Arm Description
High flow nasal cannula at 80 L/min for 10 minutes
Arm Title
HFNC 60 L/min down
Arm Type
Experimental
Arm Description
High flow nasal cannula at 60 L/min for 10 minutes
Arm Title
HFNC 40 L/min down
Arm Type
Experimental
Arm Description
High flow nasal cannula at 40 L/min for 10 minutes
Arm Title
Washout conventional facemask
Arm Type
Other
Arm Description
Again, the patients will receive oxygen therapy through conventional facemask for 10 minutes, to reduce the influence of HFNC on CPAP therapy
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
The patients will receive CPAP at 10 cmH2O for 10 minutes
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Intervention Description
Positive airway pressure applied through a sealed face mask
Intervention Type
Device
Intervention Name(s)
Facemask
Intervention Description
Oxygen therapy through a conventional facemask
Primary Outcome Measure Information:
Title
Change of global inhomogeneity index
Description
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).
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.
Secondary Outcome Measure Information:
Title
Change of Δ end expiratory lung impedance (ΔEELI)
Description
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.
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.
Title
Change of tidal impedance variation
Description
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.
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.
Title
Change of oxygenation
Description
Oxygen arterial partial pressure
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.
Title
Change of carbon dioxide
Description
Carbon dioxide arterial partial pressure
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.
Title
Change of pH
Description
Arterial 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.
Title
Change of respiratory rate
Description
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.
Title
Change of patient's comfort: modified Borg dyspnea scale
Description
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)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Comuzzi
Organizational Affiliation
Azienda Sanitaria Universitaria Integrata di Trieste
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Sanitaria Universitaria Integrata di Trieste
City
Trieste
ZIP/Postal Code
34100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Ventilation Distribution After Bariatric Surgery

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