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

Time to Reach 90% Endtidal Oxygen During Preoxygenation Clinical Trial

Official title:

Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807375
• Other study ID #: preoxygenation
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Time to Reach 90% Endtidal Oxygen During Preoxygenation

Intervention

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

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of desaturation during intubation	Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery	5 minutes
Primary	prevention of side effects of hypoxia	hypoxia-induced arrhythmia hypotension tachycardia	10 minutes