Nasal High Flow in Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04048798
• Other study ID #: 88298
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: February 2021

Study information

• Verified date: August 2019
• Source: Istanbul University
• Contact: Cigdem A BEYOGLU
• Phone: +905052278176
• Email: akyolbeyoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• Oxygen therapy via HFNC
Oxygen treatment will be applied to the patients via HFNC before and after surgery
• Oxygen therapy via face mask
Oxygen treatment will be applied to the patients via face mask before and after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (1)

Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PO2 value	PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery	24 hours
Primary	PCO2 value	PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery	24 hours