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Clinical Trials/NCT04048798
NCT04048798UnknownNot Applicable

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

Istanbul University0 sites112 target enrollmentStarted: January 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
112
Primary Endpoint
PO2 value

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Oxygen therapy via HFNC

Active Comparator

Patients who will be applied high frequency nasal cannula before and after surgery

Intervention: Oxygen therapy via HFNC (Other)

Oxygen therapy via face mask

Active Comparator

Patients who will be applied O2 via face mask before and after surgery

Intervention: Oxygen therapy via face mask (Other)

Outcomes

Primary Outcomes

PO2 value

Time Frame: 24 hours

PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery

PCO2 value

Time Frame: 24 hours

PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Cigdem Akyol Beyoğlu

Principal Investigator

Istanbul University

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