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Nasal High Flow in Bariatric Surgery

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxygen therapy via HFNC
Oxygen therapy via face mask
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Oxygen therapy via HFNC

    Oxygen therapy via face mask

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    PO2 value
    PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
    PCO2 value
    PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2019
    Last Updated
    August 6, 2019
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04048798
    Brief Title
    Nasal High Flow in Bariatric Surgery
    Official Title
    Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxygen therapy via HFNC
    Arm Type
    Active Comparator
    Arm Description
    Patients who will be applied high frequency nasal cannula before and after surgery
    Arm Title
    Oxygen therapy via face mask
    Arm Type
    Active Comparator
    Arm Description
    Patients who will be applied O2 via face mask before and after surgery
    Intervention Type
    Other
    Intervention Name(s)
    Oxygen therapy via HFNC
    Intervention Description
    Oxygen treatment will be applied to the patients via HFNC before and after surgery
    Intervention Type
    Other
    Intervention Name(s)
    Oxygen therapy via face mask
    Intervention Description
    Oxygen treatment will be applied to the patients via face mask before and after surgery
    Primary Outcome Measure Information:
    Title
    PO2 value
    Description
    PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
    Time Frame
    24 hours
    Title
    PCO2 value
    Description
    PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cigdem A BEYOGLU
    Phone
    +905052278176
    Email
    akyolbeyoglu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guniz Koksal
    Phone
    05424138505
    Email
    gunizkoksal@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cigdem A BEYOGLU
    Organizational Affiliation
    İstanbul Üniversitesi- Cerrahpaşa Cerrahpaşa Tıp Fakültesi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    I am unaware of the advantages or disadvantages of sharing IPD
    Citations:
    PubMed Identifier
    17635423
    Citation
    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. doi: 10.1111/j.1365-2044.2007.05104.x.
    Results Reference
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    Nasal High Flow in Bariatric Surgery

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