Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound
Primary Purpose
Postoperative Atelectasis, Bariatric Surgery Candidate, Ultrasound Therapy; Complications
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High flow nasal cannula oxygen is applied
High flow nasal cannula oxygen is not applied
Sponsored by
About this trial
This is an interventional screening trial for Postoperative Atelectasis
Eligibility Criteria
Inclusion Criteria:
- Above 18 years;
- Patients who have undergone obesity surgery;
- ASA 2-3 patients;
- Patients who have received written informed consent;
Exclusion Criteria:
- Patients under the age of 18;
- Patients refusing to participate in the study;
- Patients under emergency conditions;
- Earlier laryngeal and tracheal surgery;
- allergies to lidocaine;
- Patients with FEV1 / FVC below 60%
Sites / Locations
- Kocaeli Derince Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High flow nasal cannula oxygen applied
High flow nasal cannula oxygen is not applied
Arm Description
High flow nasal cannula oxygen is start at a flow rate of 80 L/min with 100% oxygen in the preoperative period.
Preoxygenation will be applied with an oxygen supplement of 5 l/min to an endtidal O2> 90%.
Outcomes
Primary Outcome Measures
Evaluation of postoperative atelectasis in bariatric surgery patients
Postoperative atelectasis develops in patients undergoing laparoscopic bariatric surgery under anesthesia.After the operation a researcher will perform lung ultrasonography postoperative at minute 5. reseracher will detect 6 region of each lung totally 12 regions. the researcher will record the modified and original lung ultrasonography scores (LUS score) of the patients. LUS Score is a scoring system to eveluate atelectasis of lung and scores 1-3 points for each region (min score 0 max score 36)
Secondary Outcome Measures
Full Information
NCT ID
NCT03828513
First Posted
December 22, 2018
Last Updated
January 16, 2023
Sponsor
Kocaeli Derince Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03828513
Brief Title
Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound
Official Title
Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound: A Randomized Controlled Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kocaeli Derince Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung ultrasound (LUS) in bariatric surgery patients.
Detailed Description
In obese patients, lung compliance decreases by 25% and Functional Residual Capacity decreases by about one-third. As they consume about 25% more oxygen than non-obese individuals, postoperative pulmonary complications occur more commonly. POINT (Peri-Operative Insufflatory Nasal Therapy) provides humidified and heated high flow oxygen therapy in perioperative period. High-flow nasal oxygen (HFNO) facilitates oxygenation and ventilation of both the spontaneously breathing and apnoeic patient.High-flow nasal cannula oxygen came to prominence in anaesthesia when it was shown to prolong the time to oxygen desaturation in patients with a difficult airway.
Lung ultrasonography (LUS) has been used more frequently in the diagnosis of pulmonary pathologies than chest radiography. This prospective observational study is to evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung ultrasound (LUS) in bariatric surgery patients.
Materials and Methods: Following the Ethics Committee approval and written informe consents, 100 adult bariatric surgery patients are include in this observational study. The patients are randomly distributed into two groups ; High Flow Nasal Cannula Oxygenation(HFNCO) made group(n:50); HFNCO not made group(n:50).
HFNCO is start at a flow rate of 20 L/min with 100% oxygen in the preoperative period. It is titrate up to 50 L/min and increase to 80 L/min under general anesthesia until tracheal intubation. Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after HFNCO.
Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.nduction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation (such as FastTrack, videolaryngoscopy or fiberoptic intubation), perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.Duration of operation, surgical method (laparotomy / laparoscopy), agents used in induction and postoperative analgesia, use of blood, blood product and vasopressor are recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atelectasis, Bariatric Surgery Candidate, Ultrasound Therapy; Complications
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula oxygen applied
Arm Type
Active Comparator
Arm Description
High flow nasal cannula oxygen is start at a flow rate of 80 L/min with 100% oxygen in the preoperative period.
Arm Title
High flow nasal cannula oxygen is not applied
Arm Type
Active Comparator
Arm Description
Preoxygenation will be applied with an oxygen supplement of 5 l/min to an endtidal O2> 90%.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula oxygen is applied
Intervention Description
Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after High flow nasal cannula oxygen. Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.Induction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation, perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula oxygen is not applied
Intervention Description
Apply preoxygenation with facemask. Prior to induction of general anesthesia, preoxygenation will be applied with an oxygen supplement of 5 l / min to an endtidal O2> 90%.Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after preoxygenation.
Primary Outcome Measure Information:
Title
Evaluation of postoperative atelectasis in bariatric surgery patients
Description
Postoperative atelectasis develops in patients undergoing laparoscopic bariatric surgery under anesthesia.After the operation a researcher will perform lung ultrasonography postoperative at minute 5. reseracher will detect 6 region of each lung totally 12 regions. the researcher will record the modified and original lung ultrasonography scores (LUS score) of the patients. LUS Score is a scoring system to eveluate atelectasis of lung and scores 1-3 points for each region (min score 0 max score 36)
Time Frame
Up to 20 minutes in postoperative care unit
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18 Years to 80 Years (Adult, Older Adult)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Above 18 years;
Patients who have undergone obesity surgery;
ASA 2-3 patients;
Patients who have received written informed consent;
Exclusion Criteria:
Patients under the age of 18;
Patients refusing to participate in the study;
Patients under emergency conditions;
Earlier laryngeal and tracheal surgery;
allergies to lidocaine;
Patients with FEV1 / FVC below 60%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Yurt, doctor
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli Derince Education and Research Hospital
City
Kocaeli
State/Province
Derince
ZIP/Postal Code
41400
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound
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