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

NCT05684900 | Completed

• 1 other identifier: DERINCETRHCELIK001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who used an oxygen mask with a reservoir during the sedation procedure in the endoscopy unit will be examined.

You may qualify if:

• Patients over the age of 18 and under the age of 70
• Patienst with have an ASA1-2 risk score

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Aydoğan Çelik

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Anesthesiology and Reanimation

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 13, 2023
• Study Start: June 10, 2022
• Primary Completion: June 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TU (1)