Determining the Effects of Foley Catheter-assisted Nasal Intubation on Nasal Bleeding in Adult Patients

NCT05072392 | Unknown

• 1 other identifier: 21-0005-A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal endotracheal intubation is a well-utilized and important endotracheal intubation route to allow good surgical access for operations involving the oral cavity. Despite its utility, there are potential complications from nasal endotracheal intubation including that of nasal bleeding, which in severe cases can impair the ability to complete the procedure. The most accepted conventional practice to decrease bleeding associated with nasal endotracheal intubation is to warm the nasal endotracheal tube prior to insertion. However, this technique still yields high rates of nasal bleeding. In 1979, correspondence by MacKinnon and Harrison in Anaesthesia described the use of a flexible urinary catheter (Foley catheter) telescoped onto the endotracheal tube tip to aid atraumatic insertion of the tube. This also served to ensure the tube was not contaminated internally by nasal secretions or blood. This has been more rigorously studied in two RCTs looking at this technique in children, but there has been no similar study in adults. This study aims to extend the evidence base of the use of this technique in adults. Our hypothesis is that the use of a flexible urinary catheter to telescopically aid nasal intubation will result in a significant decrease in the incidence and severity of nasal bleeding.

Conditions

Nasal Bleeding

Keywords

Endotracheal intubation; Nasal intubation; Epistaxis; Foley catheter; Airway

Outcome Measures

Primary Outcomes (1)

• Incidence of nasal bleeding

  Defined as the presence of blood on a folded stack of two 4x4 inch gauze swabs to the posterior oropharynx after the confirmation of successful nasotracheal intubation

  10 minutes (must be assessed prior to surgical start as this may cause additional bleeding)

Secondary Outcomes (5)

• Severity of bleeding

  10 minutes (must be assessed prior to surgical start as this may cause additional bleeding)

• Time to successful intubation

  10 minutes

• Number of attempts at intubation

  10 minutes

• Incidence of requirement to suction blood from the oral cavity to facilitate intubation

  10 minutes

• Incidence of significant postop nasal bleeding

  24 hours

Study Arms (2)

Foley-assisted

EXPERIMENTAL

The tip of the nasal endotracheal tube will be telescoped onto a 16g Foley catheter. If a ballooned catheter is used then the inflation port may be cut off prior to use. The catheter tip is then fed through the pre-selected primary nare, until the tip of the endotracheal tube is in the oropharynx. The catheter is then removed from the tip of the nasal endotracheal tube through the mouth and disposed of. If the nasal endotracheal tube is inappropriately sized, a half size above or below may be used. If difficult to pass, the anesthetist may opt to use the other side nare. Following this, the anesthetist will complete the rest of the intubation as usual.

Device: Foley catheter

Control

NO INTERVENTION

The endotracheal tube is passed through the pre-selected primary nare, until the tip of the endotracheal tube is in the oropharynx. If the nasal endotracheal tube is inappropriately sized, a half size above or below may be used. If difficult to pass, the anesthetist may choose to use the other side nare. Following this, the anesthetist will complete the rest of the intubation as usual.

Interventions

Foley catheter DEVICE

Using a 16G Foley catheter to cover the tip of the endotracheal tube as it passes through the nose. This is done in comparison to the standard practice of directly passing an endotracheal tube through the nose without a cover. Both groups use warmed endotracheal tubes and the use of topical vasoconstrictor (4 sprays of 0.1% xylometazoline to each nare).

Foley-assisted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18
• Scheduled to undergo an operation requiring nasotracheal intubation

You may not qualify if:

• Latex allergy
• Emergency surgery
• High risk of aspiration
• Anticipated or unanticipated difficult airway or bag mask ventilation
• Morbid obesity (BMI \>40)
• Bleeding diathesis
• Basal skull fracture
• Previous deviated nasal septum surgery
• Nasal polyps

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.

  PMID: 27626017 BACKGROUND

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Kong Eric You-Ten, MD PhD FRCPC

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kong Eric You-Ten, MD PhD FRCPC

CONTACT

4165864800; Eric.You-Ten@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to group allocation as they are anesthetised during the intervention procedure. The outcome assessor for the primary outcome (incidence of nasal bleeding) will also be blinded by inspecting the gauze swab for blood outside the patient's operating theatre. The care provider and investigator are unable to be blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Anesthesia

Model Details: Two parallel study groups allocated by randomization to either the intervention group (Foley-assisted nasal endotracheal intubation) or control (standard nasal endotracheal intubation). Randomisation is via sealed opaque numbered envelopes that are only opened to reveal group allocation once the patient has been recruited.

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 8, 2021
• Study Start: October 4, 2021
• Primary Completion: May 14, 2022
• Study Completion: May 14, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication

Locations

CA (1)