Airway Complication of AnesthesiaAMCNCT03550326
Evaluation of Complications in Airway Management
An observational study of Airway Complication of Anesthesia and Difficult Intubation, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Complication of Anesthesia, Difficult Intubation
- What is being tested?
- airway management
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who undergo surgery under general anesthesia and who intubate/place supraglottic airway device will be recruit for study over a period of six months
Who may be able to join
- Patients undergoing general anesthesia
- Patients to whom airway devices will be inserted
Who cannot join
- Patients who undergo surgery under regional anesthesia
- Patients who undergo surgery under sedation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Research and Training Hospital
Kocaeli, 41900
About this study
Official title: Evaluation of Complications During Airway Management: An Observational Prospective Cohort Study
In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices)
Read the detailed description
Airway management is one of the most important subject of anesthesia practice. Airway devices ,helping anesthesiologists to maintain airway safety have many complications. 4 th national audit project (NAP 4) study was designed to evaluate the incidence of the major complication of airway management. Accordingly in current study authors aim to determine the complications and incidence of the complications during airway management.
- Being tested
- airway management
- Keywords
- anesthesia, difficult airway, supraglottic airway device, difficult intubation, airway complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway managementProcedure or surgery
patients will be intubated or will be placed an airway device
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Patients who undergo general anesthesia and are intubated or inserted airway device will be enrolled. researchers will follow the induction and intubation period and record all the complications due to airway management. Receives: Procedure: airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the complications due to airway management
researchers will observe the whole patients who undergo general anesthesia and record the data
Measured: 6 months
Secondary outcomes (3)
variety of complications and reasons of the complications
researchers will observe the whole patients who undergo general anesthesia and record the data
Measured: 6 months
preventable reasons of the complications
researchers will observe the whole patients who undergo general anesthesia and record the data
Measured: 6 months
the time at which complications occurs more, during airway management
researchers will observe the whole patients who undergo general anesthesia and record the data
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jan 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zeynep Turan, Derince Training and Research Hospital
- Investigators
- tolga k saracoglu, assoc. prof., Study director, Sağlık Bilimleri Üniversitesi Kocaeli Derince SUAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550326
- Sponsor's protocol ID
- DerinceTRH-05
- Acronym
- AMC
- Status last verified
- Jul 2018
- First submitted
- 27 May 2018
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Complications During Airway Management: An Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03550326
- Acronym / sponsor ID
- AMC / DerinceTRH-05
- Keywords
- anesthesia, difficult airway, supraglottic airway device, difficult intubation, airway complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 8 Jun 2018 (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.
In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices)
Detailed description
Airway management is one of the most important subject of anesthesia practice. Airway devices ,helping anesthesiologists to maintain airway safety have many complications. 4 th national audit project (NAP 4) study was designed to evaluate the incidence of the major complication of airway management. Accordingly in current study authors aim to determine the complications and incidence of the complications during airway management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | Procedure: airway managementPatients who undergo general anesthesia and are intubated or inserted airway device will be enrolled. researchers will follow the induction and intubation period and record all the complications due to airway management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who undergo surgery under general anesthesia and who intubate/place supraglottic airway device will be recruit for study over a period of six months
Key inclusion criteria (2 listed)
- Patients undergoing general anesthesia
- Patients to whom airway devices will be inserted
Key exclusion criteria (2 listed)
- Patients who undergo surgery under regional anesthesia
- Patients who undergo surgery under sedation
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 |
|---|---|---|
| airway managementpatients will be intubated or will be placed an airway device | Procedure or surgery | general anesthesia |
Primary outcome
The incidence of the complications due to airway management
Time frame: 6 months
researchers will observe the whole patients who undergo general anesthesia and record the data
3 secondary outcomes
variety of complications and reasons of the complications
Time frame: 6 months
preventable reasons of the complications
Time frame: 6 months
the time at which complications occurs more, during airway management
Time frame: 6 months
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 11 Jul 2018.
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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.
tolga k saracoglu, assoc. prof. study director
Sağlık Bilimleri Üniversitesi Kocaeli Derince SUAM
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 Airway Complication of Anesthesia and Difficult Intubation, 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 2 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 11 Jul 2018. 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?
The incidence of the complications due to airway management (time frame: 6 months). 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 11 Jul 2018.