The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time

NCT ID: NCT03807375

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-01

Brief Summary

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The aim of the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic.

Detailed Description

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Criteria for inclusion in the study:

Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years 50 patients

1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during preoxygenation will be included.
2. Group: Patients undergoing preoxygenation without CPAP will be included

In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal CO2 value in this order will be recorded.

Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation and after intubation.

Conditions

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Time to Reach 90% Endtidal Oxygen During Preoxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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CPAP

During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed.

Group Type OTHER

CPAP preoxygenation

Intervention Type OTHER

During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.

standard preoxygenation

During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP preoxygenation

During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients between the ages of 20 and 50 years
2. American Society of Anesthesiologists I, II or III
3. Patients with body mass index of 40 and over

Exclusion Criteria

1. cardiopulmonary disease
2. patients with previous abdominal or thoracic surgery or cerebrovascular disease
3. story of intracranial hypertension or epilepsy
4. patients with a story of difficult tracheal intubation
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ilkay baran akkuş

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diskapi Yildirim Beyazit Training Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.

Reference Type BACKGROUND
PMID: 26044934 (View on PubMed)

Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.

Reference Type RESULT
PMID: 28099321 (View on PubMed)

Other Identifiers

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preoxygenation

Identifier Type: -

Identifier Source: org_study_id

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