Nasal High Flow in Bariatric Surgery

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Other: Oxygen therapy via face mask; Other: Oxygen therapy via HFNC

• Registration Number: NCT04048798
• Lead Sponsor: Istanbul University

Brief Summary

High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.

Detailed Description

Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07
• Study Start: 2020-01
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Patients with a body mass index of 40-55 kg/m2
• American Society of Anesthesiologists score II-III
• Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass

Exclusion Criteria

• Obstructive sleep apnea syndrome
• Using a non invasive mechanical ventilation device preoperatively
• Patients whoo will predicted to postanesthesia care unit admission postoperatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen therapy via face mask	Oxygen therapy via face mask	Patients who will be applied O2 via face mask before and after surgery
Oxygen therapy via HFNC	Oxygen therapy via HFNC	Patients who will be applied high frequency nasal cannula before and after surgery

Primary Outcome Measures

Name	Time	Method
PO2 value	24 hours	PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
PCO2 value	24 hours	PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery