Airway ManagementNCT06596889
The Effect of Assistive Airway Equipment on Intubation
An observational study of Airway Management and Airway Complication of Anaesthesia, run by Kocaeli City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
In this study, investigators will research the types and incidence rates of airway complications seen in the perioperative period during airway management. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Airway Complication of Anaesthesia
- What is being tested?
- Successful airway management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 870 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Mar 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was prospective and observational. There is no grouping. Oral and written informed consent will be obtained from the patients in the preoperative ward or in the preoperative preparation room of the operating room. Patients scheduled for elective operation under general anesthesia whose consents were obtained will be included in the study. Airway management techniques and equipment used will not be interfered with. After the patient's airway management is completed: the following data will be recorded. * Types of equipment: laryngoscopes, face masks, oral airways, styli, plugs, etc. * Professional experience of the airway management practitioner (in years). * If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts.
Who may be able to join
- Patients between the ages of 18 and 75.
- Patients who will undergo elective surgery.
- Patients to be operated under general anesthesia.
- Patients without difficult airway markers
Who cannot join
- Patients to be operated with emergency surgical indication.
- Patients to be operated with regional anesthesia.
- Patients with expected difficult airway markers.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli City Hospital
Kocaeli, 41100
University of Health Sciences Sanliurfa Mehmet Akif Inan Training and Research Hospital
Sanliurfa
About this study
Official title: The Effect of Assistive Airway Equipment on Intubation-Related Events in the Perioperative Period
In this study, investigators will research the types and incidence rates of airway complications seen in the perioperative period during airway management. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.
Read the detailed description
Complications related to airway management rarely occur in the operating room; however, these complications can lead to life-threatening situations. There are many studies on the types and incidence rates of airway management complications in the perioperative period. However, although the types and incidence rates of airway complications have been investigated in these studies, the effect of airway equipment used in airway management on complications has not been investigated. There are many equipment used in airway management. Laryngoscopes, face masks, oral airway devices and many assistant airway management devices are used as basic equipment. Different airway equipment may be used in each center in each case. There is no standard between centers in this regard.
In this study, investigators will primarily research the types and incidence rates of airway complications seen in the perioperative period during airway management similar to the existing literature. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.
- Being tested
- Successful airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successful airway managementProcedure or surgery
- Types of equipment: Traditional oral airways, new airways, etc.
- Professional experience of the airway management practitioner (in years).
- If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts will be recorded separately for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Not any equipment | Control group Receives: Procedure: Successful airway management | |
| Other types of equipment | Brand new oral airways Receives: Procedure: Successful airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of airway complications seen in the induction of anesthesia.
The incidence of complications (mucosal bleeding, tooth damage, etc.) that may occur during induction of anesthesia with different airway devices will be investigated.
Measured: The first 15 minutes during induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Aug 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehmet Yılmaz, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596889
- Sponsor's protocol ID
- 2024-87
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Assistive Airway Equipment on Intubation-Related Events in the Perioperative Period
- ClinicalTrials.gov ID
- NCT06596889
- Acronym / sponsor ID
- 2024-87
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 19 Sep 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.
In this study, investigators will research the types and incidence rates of airway complications seen in the perioperative period during airway management. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.
Detailed description
Complications related to airway management rarely occur in the operating room; however, these complications can lead to life-threatening situations. There are many studies on the types and incidence rates of airway management complications in the perioperative period. However, although the types and incidence rates of airway complications have been investigated in these studies, the effect of airway equipment used in airway management on complications has not been investigated. There are many equipment used in airway management. Laryngoscopes, face masks, oral airway devices and many assistant airway management devices are used as basic equipment. Different airway equipment may be used in each center in each case. There is no standard between centers in this regard.
In this study, investigators will primarily research the types and incidence rates of airway complications seen in the perioperative period during airway management similar to the existing literature. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not any equipment | – | Procedure: Successful airway managementControl group |
| Other types of equipment | – | Procedure: Successful airway managementBrand new oral airways |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was prospective and observational. There is no grouping. Oral and written informed consent will be obtained from the patients in the preoperative ward or in the preoperative preparation room of the operating room. Patients scheduled for elective operation under general anesthesia whose consents were obtained will be included in the study. Airway management techniques and equipment used will not be interfered with. After the patient's airway management is completed: the following data will be recorded. * Types of equipment: laryngoscopes, face masks, oral airways, styli, plugs, etc. * Professional experience of the airway management practitioner (in years). * If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts.
Key inclusion criteria (4 listed)
- Patients between the ages of 18 and 75.
- Patients who will undergo elective surgery.
- Patients to be operated under general anesthesia.
- Patients without difficult airway markers
Key exclusion criteria (3 listed)
- Patients to be operated with emergency surgical indication.
- Patients to be operated with regional anesthesia.
- Patients with expected difficult airway markers.
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 |
|---|---|---|
| Successful airway management* Types of equipment: Traditional oral airways, new airways, etc. * Professional experience of the airway management practitioner (in years). * If advanced, type of airway complication (bleeding, dental damage, mucosal damage, etc.), number of attempts will be recorded separately for each patient. | Procedure or surgery | Not any equipment, Other types of equipment |
Primary outcome
The incidence of airway complications seen in the induction of anesthesia.
Time frame: The first 15 minutes during induction of anesthesia
The incidence of complications (mucosal bleeding, tooth damage, etc.) that may occur during induction of anesthesia with different airway devices will be investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Airway Management
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
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.
Mehmet Yılmaz principal investigator
Kocaeli City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Airway Complication of Anaesthesia, run by Kocaeli City Hospital at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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 airway complications seen in the induction of anesthesia. (time frame: The first 15 minutes during induction of anesthesia). 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 3 Oct 2024.