Nasal High Flow in Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oxygen therapy via HFNC

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

Group Type ACTIVE_COMPARATOR

Oxygen therapy via HFNC

Intervention Type OTHER

Oxygen treatment will be applied to the patients via HFNC before and after surgery

Oxygen therapy via face mask

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

Group Type ACTIVE_COMPARATOR

Oxygen therapy via face mask

Intervention Type OTHER

Oxygen treatment will be applied to the patients via face mask before and after surgery

Interventions

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Oxygen therapy via HFNC

Oxygen treatment will be applied to the patients via HFNC before and after surgery

Intervention Type OTHER

Oxygen therapy via face mask

Oxygen treatment will be applied to the patients via face mask before and after surgery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes