Airway ManagementNCT07823179
Effect of Night Shift Versus Daytime Duty on Tracheal Intubation Complications and Duration in Surgical Patients
An observational study of Airway Management and Tracheal Intubation, run by Merve Yazici Kara.
Trial summary
Airway management is one of the most critical steps of anesthesia, and its complications can be life-threatening. Reduced staffing, differences in personnel experience, and physical and mental fatigue during off-hours (evenings, nights, weekends, and holidays) may affect the quality of care and patient safety - a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Tracheal Intubation, Intubation Complications
- What is being tested?
- Tracheal Intubation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing surgery under general anesthesia at Kocaeli City Hospital, Department of Anesthesiology and Reanimation.
Who may be able to join
- Patients older than 18 years of age
- undergoing surgery under general anesthesia
- ASA physical status I, II, or III
Who cannot join
- Patients arriving to the operating room already intubated
- Patients who do not provide written or verbal consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mehmet Yilmaz, M.D. contact
About this study
Official title: Effect of Working Hours and Night Shifts on Airway Management in Surgical Patients: A Prospective Cohort Analysis of Tracheal Intubation Complications and Duration
Airway management is one of the most critical steps of anesthesia, and its complications can be life-threatening. Reduced staffing, differences in personnel experience, and physical and mental fatigue during off-hours (evenings, nights, weekends, and holidays) may affect the quality of care and patient safety - a phenomenon described in the literature as the "after-hours effect." While this effect has been studied for outcomes such as cardiac arrest and intensive care mortality, evidence specific to airway management safety remains limited. This prospective observational cohort study aims to evaluate the effect of shift timing on the safety and efficiency of tracheal intubation in adult surgical patients undergoing general anesthesia at a single center. Based on the actual start time of anesthesia, patients will be categorized into an in-hours group (08:00-16:00) or an off-hours group (16:01-07:59), without any investigator-assigned intervention. The frequency and type of intubation-related complications, intubation duration, and the pre-intubation sleepiness level of the performing anesthesiologist (assessed using the Karolinska Sleepiness Scale) will be compared between groups. The investigators hypothesize that intubations performed during off-hours are associated with a higher complication rate and longer intubation duration than those performed during in-hours. Approximately 1000 patients will be enrolled over a period of up to 2 years.
- Being tested
- Tracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal IntubationProcedure or surgery
Standard tracheal intubation performed as part of routine general anesthesia care. The procedure itself is not assigned or altered by the investigators; all patients receive the same standard clinical care, and groups differ only in the timing of the procedure (in-hours vs. off-hours).
| Study group | Role | What they receive |
|---|---|---|
| In-hours (Group M) | Patients undergoing tracheal intubation for general anesthesia during the in-hours shift (08:00-16:00). Receives: Procedure: Tracheal Intubation | |
| Off-hours (Group D) | Patients undergoing tracheal intubation for general anesthesia during the off-hours shift (16:01-07:59), including evenings, nights, weekends, and holidays. Receives: Procedure: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Tracheal Intubation-Related Complications
Frequency and type of intubation-related complications (e.g., difficult intubation, multiple attempts, desaturation, esophageal intubation) compared between the in-hours and off-hours groups.
Measured: At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).
Tracheal Intubation Duration
Time elapsed from the first attempt to insert the airway device to the first capnographic waveform confirming successful tracheal intubation, measured in seconds.
Measured: At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).
Secondary outcomes (1)
Pre-Intubation Sleepiness Level of the Performing Anesthesiologist
Subjective sleepiness level of the physician performing the intubation, assessed immediately before the procedure using the Karolinska Sleepiness Scale (KSS, 1-9), to explore the association between fatigue and shift-related differences in intubation outcomes.
Measured: Immediately before the intubation attempt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merve Yazici Kara
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Merve Yazici Kara, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823179
- Sponsor's protocol ID
- 2026-111
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared beyond what is reported in publications resulting from this study. This is a single-center, investigator-initiated study without external funding or an established data-sharing infrastructure or repository. To protect patient privacy and comply with institutional data protection policies, de-identified individual-level data will not be made publicly available; aggregate results will be disseminated through peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Working Hours and Night Shifts on Airway Management in Surgical Patients: A Prospective Cohort Analysis of Tracheal Intubation Complications and Duration
- ClinicalTrials.gov ID
- NCT07823179
- Acronym / sponsor ID
- 2026-111
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Merve Yazici KaraOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Sep 2026 (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.
Airway management is one of the most critical steps of anesthesia, and its complications can be life-threatening. Reduced staffing, differences in personnel experience, and physical and mental fatigue during off-hours (evenings, nights, weekends, and holidays) may affect the quality of care and patient safety - a phenomenon described in the literature as the "after-hours effect." While this effect has been studied for outcomes such as cardiac arrest and intensive care mortality, evidence specific to airway management safety remains limited. This prospective observational cohort study aims to evaluate the effect of shift timing on the safety and efficiency of tracheal intubation in adult surgical patients undergoing general anesthesia at a single center. Based on the actual start time of anesthesia, patients will be categorized into an in-hours group (08:00-16:00) or an off-hours group (16:01-07:59), without any investigator-assigned intervention. The frequency and type of intubation-related complications, intubation duration, and the pre-intubation sleepiness level of the performing anesthesiologist (assessed using the Karolinska Sleepiness Scale) will be compared between groups. The investigators hypothesize that intubations performed during off-hours are associated with a higher complication rate and longer intubation duration than those performed during in-hours. Approximately 1000 patients will be enrolled over a period of up to 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-hours (Group M) | – | Procedure: Tracheal IntubationPatients undergoing tracheal intubation for general anesthesia during the in-hours shift (08:00-16:00). |
| Off-hours (Group D) | – | Procedure: Tracheal IntubationPatients undergoing tracheal intubation for general anesthesia during the off-hours shift (16:01-07:59), including evenings, nights, weekends, and holidays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgery under general anesthesia at Kocaeli City Hospital, Department of Anesthesiology and Reanimation.
Key inclusion criteria (3 listed)
- Patients older than 18 years of age
- undergoing surgery under general anesthesia
- ASA physical status I, II, or III
Key exclusion criteria (2 listed)
- Patients arriving to the operating room already intubated
- Patients who do not provide written or verbal consent
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 |
|---|---|---|
| Tracheal IntubationStandard tracheal intubation performed as part of routine general anesthesia care. The procedure itself is not assigned or altered by the investigators; all patients receive the same standard clinical care, and groups differ only in the timing of the procedure (in-hours vs. off-hours). | Procedure or surgery | In-hours (Group M), Off-hours (Group D) |
Primary outcome
Incidence of Tracheal Intubation-Related Complications
Time frame: At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).
Frequency and type of intubation-related complications (e.g., difficult intubation, multiple attempts, desaturation, esophageal intubation) compared between the in-hours and off-hours groups.
Tracheal Intubation Duration
Time frame: At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).
Time elapsed from the first attempt to insert the airway device to the first capnographic waveform confirming successful tracheal intubation, measured in seconds.
1 secondary outcome
Pre-Intubation Sleepiness Level of the Performing Anesthesiologist
Time frame: Immediately before the intubation attempt.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared beyond what is reported in publications resulting from this study. This is a single-center, investigator-initiated study without external funding or an established data-sharing infrastructure or repository. To protect patient privacy and comply with institutional data protection policies, de-identified individual-level data will not be made publicly available; aggregate results will be disseminated through peer-reviewed publication.
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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.
Mehmet Yilmaz, M.D. contact
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Tracheal Intubation, run by Merve Yazici Kara.
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 3 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Yazici Kara, M.D. (+90 533 686 01 56, merreset@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Tracheal Intubation-Related Complications (time frame: At the time of tracheal intubation (single procedural assessment, during the induction of anesthesia).). The study lists 2 primary outcomes in all. 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 16 Sep 2026.