Difficult IntubationNCT03545620
Evaluation of Intubation Rescue Techniques on Management of Difficult Airway
An observational study of Difficult Intubation and Difficult Airway, run by Derince Training and Research Hospital at 4 sites in Turkey (Türkiye).
Trial summary
When difficult airway/intubation occurs in the OR the anesthesiologist needs rescue techniques and equipment. The algorithms about management of the difficult airway don't provide adequate data. In current study researchers aim to determine most preferred rescue techniques and success rate of the chosen technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation, Difficult Airway
- What is being tested?
- rescue technique
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 3 Dec 2017to 1 Jun 2018
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent surgery under general anesthesia over 18 years old
Who may be able to join
- aged over 18 years
- patient underwent surgery under general anesthesia
Who cannot join
- pediatric patients
- patients who will intubate due to rapid serial intubation protocol
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Haydarpasa Numune Researh and Training Hospital
Istanbul
Marmara University School of Medicine
Istanbul
Derince Research and Training Hospital
Kocaeli, 41900
Kocaeli University School of Medicine
Kocaeli
About this study
Official title: Evaluation of Rescue Techniques After Failed Direct Laryngoscopy: A Multicentered Prospective Observational Study
When difficult airway/intubation occurs in the OR the anesthesiologist needs rescue techniques and equipment. The algorithms about management of the difficult airway don't provide adequate data. In current study researchers aim to determine most preferred rescue techniques and success rate of the chosen technique.
Read the detailed description
In anesthesia setting Failed tracheal intubation, leading mortality and morbidity is very important. In operation room when a Difficult intubation occured with concurrent difficult mask ventilation rapid manipulation and quick decision are lifesaving. The Presence of assistant medical personnel or rescue equipment and crisis management of physician is crucial. In anesthesia practice when difficult airway occured rescue techniques are used to facilitate the intubation but difficult airway algorithms do not provide adequate information which rescue technique should be used in a state of emergency in OR thereby current trial was designed to determine which rescue techniques are used in everyday practice to manage difficult intubation, success and complication rates of chosen techniques.
Aim of the study
- Most preferred rescue technique of the anesthesiologist When a difficult airway or difficult intubation ventilation occured
- success rate of the chosen technique
- Incidence of possible complications
- Most preferred rescue technique of the anesthesiologist on presence of the difficult mask ventilation
- Conditions
- Difficult Intubation, Difficult Airway
- Being tested
- rescue technique
- Keywords
- difficult airway, difficult intubation, videolaryngoscope, exchange catheter, fiberoptic bronchoscope, Laryngeal subglottic airway device, tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rescue techniqueDevice
which rescue technique will be preferred while established/predicted difficult airway/intubation occurs in the operation room after failed direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Difficult intubation, | Patients who underwent surgery under general anesthesia will be follow up. Patients predicted difficult intubation/airway or established difficult intubation/airway after anesthesia induction will be included. Which rescue technique will be used after unsuccessful direct laryngoscopy will be recorded. Receives: Device: rescue technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
which rescue technique will be chosen by the anesthesiologist after failed direct laryngoscopy
In case of a difficult airway situation after anesthesia induction patients will be enrolled to the study. Researchers will observe the case and record the chosen rescue technique such as video laryngoscope, supraglottic airway device, fiberoptic intubation or tracheostomy. Here the researchers aim to observe the preferred rescue method of providing an intact airway.
Measured: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
Secondary outcomes (3)
the success rate of chosen technique for providing an intact airway
Tracheal intubation or supraglottic airway device insertion period will be observed. When end tidal CO2 will be seen on the monitor patient's airway will be accepted as successfully provided. .
Measured: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
Complications due to intubation
intubation period will be observed and patients will be followed up for complications including throat pain, trauma (pharyngeal, laryngeal, teeth, palate) hypoxemia, death,
Measured: Participants will be followed for the duration of anesthesia and after induction, an expected average of 12 hour
Determination of the most preferred rescue technique for the anesthesiologists during difficult airway management.
The researchers aim to determine the most preferred rescue technique for the anesthesiologists during difficult airway management.Researchers will observe the case and record the chosen rescue technique such as video laryngoscope, supraglottic airway device, fiberoptic intubation or tracheostomy. Here the researchers aim to observe the preferred rescue method of providing an intact airway.
Measured: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start3 Dec 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 6 Months
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
- mehmet yilmaz, Study director, Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545620
- Sponsor's protocol ID
- DerinceTRH-04
- Status last verified
- Jun 2018
- First submitted
- 18 Apr 2018
- Last updated
- 21 Jun 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 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rescue Techniques After Failed Direct Laryngoscopy: A Multicentered Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03545620
- Acronym / sponsor ID
- DerinceTRH-04
- Conditions
- Difficult Intubation, Difficult Airway
- Keywords
- difficult airway, difficult intubation, videolaryngoscope, exchange catheter, fiberoptic bronchoscope, Laryngeal subglottic airway device, tracheostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Dec 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 4 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.
When difficult airway/intubation occurs in the OR the anesthesiologist needs rescue techniques and equipment. The algorithms about management of the difficult airway don't provide adequate data. In current study researchers aim to determine most preferred rescue techniques and success rate of the chosen technique.
Detailed description
In anesthesia setting Failed tracheal intubation, leading mortality and morbidity is very important. In operation room when a Difficult intubation occured with concurrent difficult mask ventilation rapid manipulation and quick decision are lifesaving. The Presence of assistant medical personnel or rescue equipment and crisis management of physician is crucial. In anesthesia practice when difficult airway occured rescue techniques are used to facilitate the intubation but difficult airway algorithms do not provide adequate information which rescue technique should be used in a state of emergency in OR thereby current trial was designed to determine which rescue techniques are used in everyday practice to manage difficult intubation, success and complication rates of chosen techniques.
Aim of the study
- Most preferred rescue technique of the anesthesiologist When a difficult airway or difficult intubation ventilation occured
- success rate of the chosen technique
- Incidence of possible complications
- Most preferred rescue technique of the anesthesiologist on presence of the difficult mask ventilation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Difficult intubation, | – | Device: rescue techniquePatients who underwent surgery under general anesthesia will be follow up. Patients predicted difficult intubation/airway or established difficult intubation/airway after anesthesia induction will be included. Which rescue technique will be used after unsuccessful direct laryngoscopy will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent surgery under general anesthesia over 18 years old
Key inclusion criteria (2 listed)
- aged over 18 years
- patient underwent surgery under general anesthesia
Key exclusion criteria (2 listed)
- pediatric patients
- patients who will intubate due to rapid serial intubation protocol
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 |
|---|---|---|
| rescue techniquewhich rescue technique will be preferred while established/predicted difficult airway/intubation occurs in the operation room after failed direct laryngoscopy | Device | Difficult intubation, |
Primary outcome
which rescue technique will be chosen by the anesthesiologist after failed direct laryngoscopy
Time frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
In case of a difficult airway situation after anesthesia induction patients will be enrolled to the study. Researchers will observe the case and record the chosen rescue technique such as video laryngoscope, supraglottic airway device, fiberoptic intubation or tracheostomy. Here the researchers aim to observe the preferred rescue method of providing an intact airway.
3 secondary outcomes
the success rate of chosen technique for providing an intact airway
Time frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
Complications due to intubation
Time frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 12 hour
Determination of the most preferred rescue technique for the anesthesiologists during difficult airway management.
Time frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
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 21 Jun 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.
mehmet yilmaz study director
Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation and Difficult Airway, run by Derince Training and Research Hospital at 4 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 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
which rescue technique will be chosen by the anesthesiologist after failed direct laryngoscopy (time frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour). 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 21 Jun 2018.