Intubation; Difficult or FailedNCT06002815
Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients
An observational study of Intubation; Difficult or Failed, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- How many people
- 244 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2023to 28 Mar 2024
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study.
Who may be able to join
None listed.
Who cannot join
- Patients under 18 year-old
- Patients who do not require nasogastric tube insertion
- Patients with anatomical changes in the head and neck region
- Patients without an informed consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Taksim Training and Research Hospital
Istanbul, Please Select, 34433
About this study
This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients.
Read the detailed description
Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. Two groups will be formed, the easy airway group and the difficult airway group. The main aim is to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion. Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim. At the end of the study, determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.
- Conditions
- Intubation; Difficult or Failed
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients
The main aim was to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion
Measured: 10 minutes
Secondary outcomes (2)
Complications in Difficult and Easy Airway Patients
Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim
Measured: 5 minutes
Airway parameters and failure of nasogastric tube insertion
Determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Aug 2023
- Primary completion28 Feb 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 244 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Celal Kaya, MD, Principal investigator, Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002815
- Sponsor's protocol ID
- 2023.07.IRB.78
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients
- ClinicalTrials.gov ID
- NCT06002815
- Acronym / sponsor ID
- 2023.07.IRB.78
- Conditions
- Intubation; Difficult or Failed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 21 Aug 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.
This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients.
Detailed description
Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. Two groups will be formed, the easy airway group and the difficult airway group. The main aim is to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion. Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim. At the end of the study, determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients under 18 year-old
- Patients who do not require nasogastric tube insertion
- Patients with anatomical changes in the head and neck region
- Patients without an informed consent form
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
Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients
Time frame: 10 minutes
The main aim was to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion
2 secondary outcomes
Complications in Difficult and Easy Airway Patients
Time frame: 5 minutes
Airway parameters and failure of nasogastric tube insertion
Time frame: 10 minutes
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 2 May 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Celal Kaya, MD principal investigator
Taksim Training and Research Hospital
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 Intubation; Difficult or Failed, run by Taksim Egitim ve Arastirma Hastanesi 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 0 inclusion and 4 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 2 May 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. 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?
Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients (time frame: 10 minutes). 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 2 May 2024.