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

Sponsor
Kocaeli Derince Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03828513
Collaborator
(none)
100
1
2
55
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High flow nasal cannula oxygen is applied
  • Device: High flow nasal cannula oxygen is not applied
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound: A Randomized Controlled Prospective Study
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of postoperative atelectasis in bariatric surgery patients [Up to 20 minutes in postoperative care unit]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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%

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli Derince Education and Research Hospital Kocaeli Derince Turkey 41400

Sponsors and Collaborators

  • Kocaeli Derince Education and Research Hospital

Investigators

  • Principal Investigator: Emine Yurt, doctor, Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EMİNE YURT, Principal Investigator, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT03828513
Other Study ID Numbers:
  • KIA 2018/174
First Posted:
Feb 4, 2019
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022