Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound

Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound: A Randomized Controlled Prospective Study

Evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung ultrasound (LUS) in bariatric surgery patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Bariatric Surgery Candidate; Ultrasound Therapy; Complications; Postoperative Atelectasis
• Intervention / Treatment: Device: High flow nasal cannula oxygen is applied; Device: High flow nasal cannula oxygen is not applied

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Derince
    • Kocaeli, Derince, Turkey, 41400
      • Kocaeli Derince Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Above 18 years;
2. Patients who have undergone obesity surgery;
3. ASA 2-3 patients;
4. Patients who have received written informed consent;

Exclusion Criteria:

1. Patients under the age of 18;
2. Patients refusing to participate in the study;
3. Patients under emergency conditions;
4. Earlier laryngeal and tracheal surgery;
5. allergies to lidocaine;
6. Patients with FEV1 / FVC below 60%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High flow nasal cannula oxygen applied; High flow nasal cannula oxygen is start at a flow rate of 80 L/min with 100% oxygen in the preoperative period.	Device: High flow nasal cannula oxygen is applied; 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.
Active Comparator: High flow nasal cannula oxygen is not applied; Preoxygenation will be applied with an oxygen supplement of 5 l/min to an endtidal O2> 90%.	Device: High flow nasal cannula oxygen is not applied; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 20 minutes in postoperative care unit

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital
• Investigators: Principal Investigator: Emine Yurt, doctor, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: KIA 2018/174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No