The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time
Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 5, 2019
January 1, 2019
1.2 years
January 10, 2019
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevention of desaturation during intubation
Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery
5 minutes
prevention of side effects of hypoxia
hypoxia-induced arrhythmia hypotension tachycardia
10 minutes
Study Arms (2)
CPAP
OTHERDuring 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.
standard preoxygenation
NO INTERVENTIONDuring 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.
Interventions
During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
Eligibility Criteria
You may qualify if:
- Patients between the ages of 20 and 50 years
- American Society of Anesthesiologists I, II or III
- Patients with body mass index of 40 and over
You may not qualify if:
- cardiopulmonary disease
- patients with previous abdominal or thoracic surgery or cerebrovascular disease
- story of intracranial hypertension or epilepsy
- patients with a story of difficult tracheal intubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training Research Hospital
Ankara, Turkey (Türkiye)
Related Publications (2)
Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.
PMID: 26044934BACKGROUNDNimmagadda 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.
PMID: 28099321RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 16, 2019
Study Start
March 1, 2018
Primary Completion
May 1, 2019
Study Completion
June 1, 2019
Last Updated
July 5, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share