Research of the Effect of Reservoir Oxygen Mask Application on Respiratory Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy

Oxygen Deficiency Clinical Trial

Official title:

Research of the Effect of Reservoir Oxygen Mask Application on Respiratory and Hemodynamic Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684900
• Other study ID #: DERINCETRHCELIK001
• Status: Completed
• Start date: June 10, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: December 2023
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the oxygen mask with reservoir, oxygen can be given to patients with FiO2 values that can reach 80-100%. Reservoir oxygen mask is superior to other oxygen treatment methods with the high oxygen rate applied.Our hypothesis is that the use of an oxygen mask with a reservoir will reduce the incidence of respiratory complications in adult patients who will undergo sedation in the endoscopy unit.

Description:

During the sedation procedure in the endoscopy unit, patients who used a reservoir oxygen mask will be examined. Patients over the age of 18 and under the age of 70, with ASA 1-2 risk score, who are planned to be operated under sedation in the endoscopy unit of our hospital will be included. Patients who do not have verbal and written consent to participate in the study, have an ASA3-4 risk score, and are scheduled for emergency procedures will be excluded from the study. No premedication will be applied to patients admitted to the endoscopy unit. As a standard, intravenous vascular access will be established with a 22 gauge intraket on the back of the left hand in all patients, 6-10 lt/minute oxygen therapy will be started with a reservoir mask, and peripheral oxygen saturation, end-tidal CO2, blood pressure arterial values will be monitored and recorded. These parameters will be monitored and recorded every five minutes during the procedure. In addition, the sedative agents applied to the patients and their doses will be recorded. After the procedure, all patients will be taken to the recovery room, where they will be observed until the modified aldrete score is 9 or higher. The recovery times of the patients, nausea, vomiting and similar symptoms will be followed and recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients over the age of 18 and under the age of 70

• Patienst with have an ASA1-2 risk score

Exclusion Criteria:

• Patients who do not have verbal and written consent to participate in the study

• Patienst with have an ASA3-4 risk score,

• Patients scheduled for emergency intervention.

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Locations

Country	Name	City	State
Turkey	Aydogan Çelik	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-anaesthetic discharge scoring criteria	In the modified aldrete scoring system, 5 criteria such as activity, respiration, circulation, consciousness and oxygen saturation are evaluated.Patients with a modified Aldrete score of 9 and above can be sent to the service.	up to 2 HOUR