Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514690
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-04-29
Brief Title:
Postoperative Memories and Level of Sedation for Tracheal Intubation Using Fiberoptic BronchoscopyVideolaryngoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Memories and Optimal Level of Sedation for Tracheal Intubation Using Fiberoptic BronchoscopyVidolaryngoscopy in Patients With Anticipated Difficult Airway Undergoing Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 bronchoscopyvideolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation Patients with an unexpected difficult airway under 18 years of age andor 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 bronchoscopicvideolaryngoscopic 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
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 bronchoscopyvideolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation Patients with an unexpected difficult airway under 18 years of age andor 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 bronchoscopicvideolaryngoscopic 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 bronchoscopyvideolaryngoscopy
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 bronchoscopyvideolaryngoscopy
Exclusion criteria
Patients 18 years
Patients without expected difficult airway
Patients with cognitive impairment Informed consent for anesthesia will specify the need for fiberoptic bronchoscopyvideolaryngoscopy for tracheal intubation and will require the patients written authorization to participate in this study
Before performing fiberoptic bronchoscopyvideolaryngoscopy 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 bronchoscopyvideolaryngoscopy intravenous sedation drugs administered and their doses nasal instillation spray pharyngeal spray andor 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 bronchoscopicvideolaryngoscopic 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
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 bronchoscopyvideolaryngoscopy
Exclusion criteria
Patients 18 years
Patients without expected difficult airway
Patients with cognitive impairment Informed consent for anesthesia will specify the need for fiberoptic bronchoscopyvideolaryngoscopy for tracheal intubation and will require the patients written authorization to participate in this study
Before performing fiberoptic bronchoscopyvideolaryngoscopy 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 bronchoscopyvideolaryngoscopy intravenous sedation drugs administered and their doses nasal instillation spray pharyngeal spray andor 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 bronchoscopicvideolaryngoscopic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None