Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03975348
Study type Interventional
Source University of Trieste
Contact
Status Completed
Phase N/A
Start date April 15, 2019
Completion date September 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A