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

NCT ID: NCT05684900

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2023-11-10

Brief 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.

Detailed 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.

Conditions

Oxygen Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

reservoir oxygen mask

During the sedation procedure in the endoscopy unit, patients who used a reservoir oxygen mask will be examined. 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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derince Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aydoğan Çelik

MD,Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aydoğan Çelik

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DERINCETRHCELIK001

Identifier Type: -

Identifier Source: org_study_id