Gastric DiseaseNCT06273319
The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications
A study testing OXYGEN THERAPY in people with Gastric Disease and Gastric Distress, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Disease, Gastric Distress
- What is being tested?
- OXYGEN THERAPY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 1 Jun 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY
Who cannot join
- Chronic obstructive pulmonary disease Having low saturation Lung cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxygen Administration With Double Nasal Cannula on Respiratory Complications in Endoscopies
To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.
Read the detailed description
Two groups of patients scheduled for gastrointestinal endoscopy will be compared in terms of desaturation and respiratory complications by applying 15 litres of oxygen therapy to the first group and 30 litres to the second group with double nasal cannula.
- Conditions
- Gastric Disease, Gastric Distress
- Being tested
- OXYGEN THERAPY
- Keywords
- Desaturation, oxygen therapy, Sedoanalgesia
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXYGEN THERAPYDrug
15 AND 30 LT OXYGEN TREATMENT
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients who will receive 15 litres oxygen therapy | Placebo comparator | : Patients who will receive 15 litres oxygen therapy, will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure. Receives: Drug: OXYGEN THERAPY |
| Group 2: Patients who will receive 30 litres oxygen therapy | Active comparator | Patients who will receive 30 litres oxygen therapy,will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure. Receives: Drug: OXYGEN THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%
Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DiseaseStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU DEMİROZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273319
- Sponsor's protocol ID
- 010656
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxygen Administration With Double Nasal Cannula on Respiratory Complications in Endoscopies
- ClinicalTrials.gov ID
- NCT06273319
- Acronym / sponsor ID
- 010656
- Conditions
- Gastric Disease, Gastric Distress
- Keywords
- Desaturation, oxygen therapy, Sedoanalgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.
Detailed description
Two groups of patients scheduled for gastrointestinal endoscopy will be compared in terms of desaturation and respiratory complications by applying 15 litres of oxygen therapy to the first group and 30 litres to the second group with double nasal cannula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients who will receive 15 litres oxygen therapy | Placebo comparator | Drug: OXYGEN THERAPY: Patients who will receive 15 litres oxygen therapy, will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure. |
| Group 2: Patients who will receive 30 litres oxygen therapy | Active comparator | Drug: OXYGEN THERAPYPatients who will receive 30 litres oxygen therapy,will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY
Key exclusion criteria (1 listed)
- Chronic obstructive pulmonary disease Having low saturation Lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OXYGEN THERAPY15 AND 30 LT OXYGEN TREATMENT | Drug | Group 1: Patients who will receive 15 litres oxygen therapy, Group 2: Patients who will receive 30 litres oxygen therapy |
Primary outcome
Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%
Time frame: Up to 24 weeks
Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OXYGEN THERAPY in people with Gastric Disease and Gastric Distress, run by Inonu University 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 1 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DUYGU DEMIROZ, dr (+905319504421, drduygudemiroz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95% (time frame: Up to 24 weeks). 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 22 Feb 2024.