Ventilation Distribution After Bariatric Surgery

Evaluation of Ventilation Distribution After Bariatric Surgery - High Flow Nasal Cannulas Versus Continuous Positive Airway Pressure

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Atelectasis, Postoperative Pulmonary
• Intervention / Treatment: Device: Facemask; Device: High flow nasal cannula; Device: Continuous positive airway pressure

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: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34100
    • Azienda Sanitaria Universitaria Integrata di Trieste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Baseline conventional facemask; The patients will receive oxygen therapy through conventional facemask for 10 minutes	Device: Facemask; Oxygen therapy through a conventional 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	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 60 L/min up; High flow nasal cannula at 60 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 80 L/min up; High flow nasal cannula at 80 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 100 L/min; High flow nasal cannula at 100 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 80 L/min down; High flow nasal cannula at 80 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 60 L/min down; High flow nasal cannula at 60 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
EXPERIMENTAL: HFNC 40 L/min down; High flow nasal cannula at 40 L/min for 10 minutes	Device: High flow nasal cannula; High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
OTHER: 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	Device: Facemask; Oxygen therapy through a conventional facemask
ACTIVE_COMPARATOR: CPAP; The patients will receive CPAP at 10 cmH2O for 10 minutes	Device: Continuous positive airway pressure; Positive airway pressure applied through a sealed face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
Change of oxygenation	Oxygen arterial partial pressure	The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other.
Change of carbon dioxide	Carbon dioxide arterial partial pressure	The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other.
Change of pH	Arterial pH	The blood gas analysis will be performed at minute 10, 20, 50, 90 and 100. The values will then all be compared each other.
Change of respiratory rate	Respiratory rate	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.
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)	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.

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Principal Investigator: Lucia Comuzzi, Azienda Sanitaria Universitaria Integrata di Trieste

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Bariatric surgery; High flow nasal cannula; Electrical impedance tomography; Postoperative atelectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 123/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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