Oxygen DeficiencyNCT05684900
Research of the Effect of Reservoir Oxygen Mask Application on Respiratory Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy
An observational study of Oxygen Deficiency, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 10 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who used an oxygen mask with a reservoir during the sedation procedure in the endoscopy unit will be examined.
Who may be able to join
- Patients over the age of 18 and under the age of 70
- Patienst with have an ASA1-2 risk score
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research of the Effect of Reservoir Oxygen Mask Application on Respiratory and Hemodynamic Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy
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.
Read the 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
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start10 Jun 2022
- Primary completion10 Jun 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydoğan Çelik, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684900
- Sponsor's protocol ID
- DERINCETRHCELIK001
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Effect of Reservoir Oxygen Mask Application on Respiratory and Hemodynamic Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy
- ClinicalTrials.gov ID
- NCT05684900
- Acronym / sponsor ID
- DERINCETRHCELIK001
- Conditions
- Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who used an oxygen mask with a reservoir during the sedation procedure in the endoscopy unit will be examined.
Key inclusion criteria (2 listed)
- Patients over the age of 18 and under the age of 70
- Patienst with have an ASA1-2 risk score
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-anaesthetic discharge scoring criteria
Time frame: up to 2 HOUR
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Deficiency, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-anaesthetic discharge scoring criteria (time frame: up to 2 HOUR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.