NCT03828513

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

7 years

First QC Date

December 22, 2018

Last Update Submit

January 21, 2025

Conditions

Postoperative AtelectasisBariatric Surgery CandidateUltrasound Therapy; Complications

Outcome Measures

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)

    Up to 20 minutes in postoperative care unit

Study Arms (2)

High flow nasal cannula oxygen applied

ACTIVE COMPARATOR

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

High flow nasal cannula oxygen is not applied

ACTIVE COMPARATOR

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

High flow nasal cannula oxygen is appliedDEVICE

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 applied
High flow nasal cannula oxygen is not appliedDEVICE

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.

High flow nasal cannula oxygen is not applied

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18 Years to 80 Years (Adult, Older Adult)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Education and Research Hospital

Kocaeli, Derince, 41400, Turkey (Türkiye)

Location

Study Officials

  • Emine Yurt, doctor

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2018

First Posted

February 4, 2019

Study Start

March 1, 2018

Primary Completion

February 28, 2025

Study Completion

March 30, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)