Postoperative Memories and Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Videolaryngoscopy

NCT06514690 | Recruiting

• 1 other identifier: EOM(AG)014/2023(6107)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Difficult Airway; Postoperative Memories; Tracheal Intubation

Keywords

postoperative memories; tracheal intubation; difficult airway

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after tracheal extubation and 30 days after

Secondary Outcomes (1)

• Determine other adverse effects:

  during fiberoptic bronchoscopy/videolaryngoscopy procedure

Study Arms (2)

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.

Other: Sedation

Patients intubated by videolaryngoscopy

The videolaryngoscopy allows tracheal intubation by introducing a laryngoscope and visualizing the glottis on an external display.

Other: Sedation

Interventions

Sedation OTHER

Different degrees of intravenous sedation according to the Ramsay scale

Patients intubated by fiberoptic bronchoscope; Patients intubated by videolaryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients older than 18 years
• Patients undergoing surgery
• Patients with predicted difficult airway

You may not qualify if:

• Patients under 18 years of age
• Patients without cognitive disorders

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (2)

Susana González Suárez

Barcelona, Catalonia, 08035, Spain

RECRUITING

Susana González Suárez

Barcelona, Catalonia, 08035, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: July 23, 2024
• Study Start: April 29, 2023
• Primary Completion: April 29, 2025
• Study Completion: May 29, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)