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Active, not recruitingNCT03828513Updated Jan 22, 2025

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

An interventional study of High flow nasal cannula oxygen is applied and High flow nasal cannula oxygen is not applied in Postoperative Atelectasis, Bariatric Surgery Candidate and Ultrasound Therapy; Complications, sponsored by Kocaeli Derince Education and Research Hospital. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Kocaeli Derince Education and Research Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as active, not recruiting.
  • Registered 9 months after the study started (first participant enrolled Mar 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Postoperative Atelectasis
  • Bariatric Surgery Candidate
  • Ultrasound Therapy; Complications

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03

In context

Pulmonary Atelectasis

377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Kocaeli Derince Education and Research Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 / FVC below 60%
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceHigh 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.

  • DeviceHigh 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 20 minutes in postoperative care unit

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Study locations

1 site
  • Kocaeli Derince Education and Research Hospital
    Kocaeli, Derince 41400, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Feb 2025, 83 months after the start.

Of 152 non-industry interventional studies with no phase under Pulmonary Atelectasis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 83 months is above that.

Counting every sponsor, half of 154 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2018
First posted
Feb 4, 2019
StartActual
Mar 1, 2018
Primary completionEst.
Feb 28, 2025
CompletionEst.
Mar 30, 2025
Last update
Jan 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03828513
Lead sponsor
Kocaeli Derince Education and Research Hospital
Responsible party
EMİNE YURT (Principal Investigator, Kocaeli Derince Education and Research Hospital) — Principal investigator
First posted
Feb 4, 2019
Start date
Mar 1, 2018
Primary completion
Feb 28, 2025 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Jan 22, 2025

Study contacts

Emine Yurt, doctor
principal investigator · Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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