Difficult AirwayNCT06514690
Postoperative Memories and Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Videolaryngoscopy
An observational study of Difficult Airway and Postoperative Memories, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway, Postoperative Memories, Tracheal Intubation
- What is being tested?
- Sedation
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Apr 2023to 29 May 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients older than 18 years undergoing surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation.
Who may be able to join
- Patients older than 18 years
- Patients undergoing surgery
- Patients with predicted difficult airway
Who cannot join
- Patients under 18 years of age
- Patients without cognitive disorders
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Susana González Suárez
Barcelona, Catalonia, 08035
Susana González-Suárez, MD; PhD, 636272697, susana.gonzalez@vallhebron.cat
- Recruiting
Susana González Suárez
Barcelona, Catalonia, 08035
Susana González Súarez, PhD, 636272697, susana.gonzalez@vallhebron.cat
About this study
Official title: Postoperative Memories and Optimal Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Vidolaryngoscopy in Patients With Anticipated Difficult Airway Undergoing Surgery
Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation.
Objective: To determine and compare the existence of postoperative memories of the patients and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.
Read more
Methods Prospective observational study that includes 100 patients older than 18 years who are going to undergo surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation. Patients with an unexpected difficult airway, under 18 years of age and/or with cognitive impairment will be excluded. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.
Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.
Read the detailed description
Background In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation. The intravenous sedation has the advantages of relieving anxiety, providing maximum comfort to the patient, facilitating examination, and producing amnesia of the episode. As an inconvenience, it can produce a depression of the respiratory system, fearsome in patients with expected difficult airway. Given the fear of the appearance of respiratory depression in these patients, the levels of sedation achieved are usually not very deep, and there may be pain and the presence of unpleasant postoperative memories in relation to the intubation technique using bronchoscopy/videolaryngoscopy.
Main objective: To determine and compare the existence of postoperative memories of patients who need conscious tracheal intubation, but under the effects of sedation, due to the planned difficult airway, depending on whether intubation was performed with a fiberoptic bronchoscope or video laryngoscope.
Secondary objective: To determine if there is a relationship between the appearance of postoperative memories and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.
Other objectives: To determine if the duration of tracheal intubation time influences the incidence of postoperative memories. Determine the incidence of respiratory depression (SpO2 <90%) during the tracheal intubation procedure. Pain presented by patients during the procedure.
Methods Prospective observational study
Inclusion criteria:
- Patients older than 18 years
- Patients with predicted difficult airway who need surgery
- Patients undergoing tracheal intubation using fiberoptic bronchoscopy/videolaryngoscopy
Exclusion criteria:
- Patients <18 years.
- Patients without expected difficult airway
- Patients with cognitive impairment, Informed consent for anesthesia will specify the need for fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation and will require the patient's written authorization to participate in this study.
Before performing fiberoptic bronchoscopy/videolaryngoscopy, the patient will be monitored (blood pressure, ECG, SpO2) and O2 will be administered to try to maintain SpO2 levels above 90%. Next, we will proceed to intravenous sedation. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.
The level of sedation obtained during the tracheal intubation procedure can be any of those classified on the Ramsay scale, at the discretion of the anesthesiologist.
For each study group (fibrebronchoscope-videolaryngoscope) the following will be recorded: the demographic characteristics of the patients; the type of surgery and its duration; duration of fiberoptic bronchoscopy/videolaryngoscopy; intravenous sedation drugs administered and their doses; nasal (instillation, spray), pharyngeal (spray) and/or vocal cord (instillation) administration of lidocaine; the existence of respiratory depression (lower peripheral oxygen saturation (SpO2) level); the highest and lowest systolic blood pressure (SBP) and heart rate (HR) values; the lowest bispectral index (BIS) value; and the time that the patient remains intubated after surgery.
Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.
- Being tested
- Sedation
- Keywords
- postoperative memories, tracheal intubation, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationOther
Different degrees of intravenous sedation according to the Ramsay scale
| Study group | Role | What they receive |
|---|---|---|
| Patients intubated by fiberoptic bronchoscope | Fiberoptic bronchoscopy involves the introduction of a flexible tube (bronchoscope) through the nose that has a light and a video camera at its tip. It allows directing the orotracheal tube into the airway. Receives: Other: Sedation | |
| Patients intubated by videolaryngoscopy | The videolaryngoscopy allows tracheal intubation by introducing a laryngoscope and visualizing the glottis on an external display. Receives: Other: Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postperative memories
- Determine and compare, between study groups, the existence of postoperative memories according to Brice's questionnaire, in patients who need conscious tracheal intubation, under the effects of intravenous sedation.
- Determine and compare, between study groups, postoperative memories for each sedation level of the Ramsay scale.
Measured: 24 hours after tracheal extubation and 30 days after
Secondary outcomes (1)
Determine other adverse effects:
Record patients who present respiratory depression (SpO2 <90%), discomfort (cough and movements)
Measured: during fiberoptic bronchoscopy/videolaryngoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start29 Apr 2023
- Primary completion29 Apr 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514690
- Sponsor's protocol ID
- EOM(AG)014/2023(6107)
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2023
- Last updated
- 13 Aug 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Memories and Optimal Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Vidolaryngoscopy in Patients With Anticipated Difficult Airway Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06514690
- Acronym / sponsor ID
- EOM(AG)014/2023(6107)
- Keywords
- postoperative memories, tracheal intubation, difficult airway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 29 Apr 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 23 Jul 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.
Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation.
Objective: To determine and compare the existence of postoperative memories of the patients and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.
Methods Prospective observational study that includes 100 patients older than 18 years who are going to undergo surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation. Patients with an unexpected difficult airway, under 18 years of age and/or with cognitive impairment will be excluded. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.
Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.
Detailed description
Background In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation. The intravenous sedation has the advantages of relieving anxiety, providing maximum comfort to the patient, facilitating examination, and producing amnesia of the episode. As an inconvenience, it can produce a depression of the respiratory system, fearsome in patients with expected difficult airway. Given the fear of the appearance of respiratory depression in these patients, the levels of sedation achieved are usually not very deep, and there may be pain and the presence of unpleasant postoperative memories in relation to the intubation technique using bronchoscopy/videolaryngoscopy.
Main objective: To determine and compare the existence of postoperative memories of patients who need conscious tracheal intubation, but under the effects of sedation, due to the planned difficult airway, depending on whether intubation was performed with a fiberoptic bronchoscope or video laryngoscope.
Secondary objective: To determine if there is a relationship between the appearance of postoperative memories and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.
Other objectives: To determine if the duration of tracheal intubation time influences the incidence of postoperative memories. Determine the incidence of respiratory depression (SpO2 <90%) during the tracheal intubation procedure. Pain presented by patients during the procedure.
Methods Prospective observational study
Inclusion criteria:
- Patients older than 18 years
- Patients with predicted difficult airway who need surgery
- Patients undergoing tracheal intubation using fiberoptic bronchoscopy/videolaryngoscopy
Exclusion criteria:
- Patients <18 years.
- Patients without expected difficult airway
- Patients with cognitive impairment, Informed consent for anesthesia will specify the need for fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation and will require the patient's written authorization to participate in this study.
Before performing fiberoptic bronchoscopy/videolaryngoscopy, the patient will be monitored (blood pressure, ECG, SpO2) and O2 will be administered to try to maintain SpO2 levels above 90%. Next, we will proceed to intravenous sedation. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.
The level of sedation obtained during the tracheal intubation procedure can be any of those classified on the Ramsay scale, at the discretion of the anesthesiologist.
For each study group (fibrebronchoscope-videolaryngoscope) the following will be recorded: the demographic characteristics of the patients; the type of surgery and its duration; duration of fiberoptic bronchoscopy/videolaryngoscopy; intravenous sedation drugs administered and their doses; nasal (instillation, spray), pharyngeal (spray) and/or vocal cord (instillation) administration of lidocaine; the existence of respiratory depression (lower peripheral oxygen saturation (SpO2) level); the highest and lowest systolic blood pressure (SBP) and heart rate (HR) values; the lowest bispectral index (BIS) value; and the time that the patient remains intubated after surgery.
Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients intubated by fiberoptic bronchoscope | – | Other: SedationFiberoptic bronchoscopy involves the introduction of a flexible tube (bronchoscope) through the nose that has a light and a video camera at its tip. It allows directing the orotracheal tube into the airway. |
| Patients intubated by videolaryngoscopy | – | Other: SedationThe videolaryngoscopy allows tracheal intubation by introducing a laryngoscope and visualizing the glottis on an external display. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years undergoing surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients undergoing surgery
- Patients with predicted difficult airway
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients without cognitive disorders
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 |
|---|---|---|
| SedationDifferent degrees of intravenous sedation according to the Ramsay scale | Other | Patients intubated by fiberoptic bronchoscope, Patients intubated by videolaryngoscopy |
Primary outcome
Incidence of postperative memories
Time frame: 24 hours after tracheal extubation and 30 days after
* Determine and compare, between study groups, the existence of postoperative memories according to Brice's questionnaire, in patients who need conscious tracheal intubation, under the effects of intravenous sedation. * Determine and compare, between study groups, postoperative memories for each sedation level of the Ramsay scale.
1 secondary outcome
Determine other adverse effects:
Time frame: during fiberoptic bronchoscopy/videolaryngoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 Difficult Airway and Postoperative Memories, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
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: status not confirmed, as of the sponsor's last update on 13 Aug 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postperative memories (time frame: 24 hours after tracheal extubation and 30 days after). 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 13 Aug 2024.