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

NCT ID: NCT03828513

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2025-03-30

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.

Conditions

Postoperative Atelectasis; Bariatric Surgery Candidate; Ultrasound Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High flow nasal cannula oxygen is applied

Intervention Type: DEVICE

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.

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%.

Group Type: ACTIVE_COMPARATOR

High flow nasal cannula oxygen is not applied

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

EMİNE YURT

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine Yurt, doctor

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Kocaeli Derince Education and Research Hospital

Kocaeli, Derince, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KIA 2018/174

Identifier Type: -

Identifier Source: org_study_id