No registrations found.
ID
Source
Health condition
Epistaxis
Nasal intubation
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Severity of the epistaxis:
o none/slight/moderate/severe
o requiring suction: yes/no
• Navigability of the tube during nasal passage (smooth or impinged)
Secondary outcome
• Number of attempts
• Resistance during intubation
• Difficulty of intubation (grade of intubation)
• Evaluation of nasal complications:
o Persistent nasal bleeding
o Nasal pain (NRS-score)
o Nasal trauma
o Difficulty of nasal breathing
Background summary
Rationale: Nasotracheal intubation is a frequently employed intubation technique, but passage of the tube through the nasal cavity may lacerate the mucosa, and create a fausse route. In the present study we therefore aim to evaluate whether a new strategy that combines application of a decongestivum in combination with dilation of the nasal cavity reduces nasal trauma during nasotracheal intubation. We hypothesize that preoperative application of xylomethazoline and polyvinyl-alcohol nasal dilator will facilitate nasotracheal intubation and reduce epistaxis after nasal intubation.
Objective: The main purpose of this study is to investigate the clinical efficacy of xylomethazoline, combined with dilating the nasal passage way with polyvinyl-alcohol nasal dilator in the prevention of iatrogenic epistaxis after nasotracheal intubation. The secondary objective is to investigate the clinical efficacy of xylomethazoline and with polyvinyl-alcohol nasal packaging to dilating the nasal passage way in the passage of the nasotracheal tube during nasal intubation.
Study design: This study is a randomized controlled trial with non-invasive measurements. It is a blinded, prospective study.
Study population: All adult (≥18 years old) patients requiring nasal intubation in Catharina Hospital Eindhoven are eligible to participate in this study. Patients with COPD Gold 3 or 4, severe dyspnoea, (history of) nasal trauma or anatomical deformities or known allergy to any of the medications used will be excluded.
Intervention: 60 minutes before the planned surgery the patient will receive xylomethazoline intranasally followed by a polyvinyl-alcohol (PVA) nasal dressing (Merocel®) as a mechanical dilator in both nostrils.
Standard care: xylometazoline will be applicated in both nostrils shortly (5 minutes) before the induction of anesthesia.
Main study parameters/endpoints: The main study parameters are the severity of epistaxis and the navigability of the nasal passage.
Study objective
Nasotracheal intubation is a frequently employed intubation technique, but passage of the tube through the nasal cavity may lacerate the mucosa, and create a fausse route. In the present study we therefore aim to evaluate whether a new strategy that combines application of a decongestivum in combination with dilation of the nasal cavity reduces nasal trauma during nasotracheal intubation. We hypothesize that preoperative application of xylomethazoline and polyvinyl-alcohol nasal dilator will facilitate nasotracheal intubation and reduce epistaxis after nasal intubation.
Study design
- during nasal intubation
- after intubation
- during postoperative recovery the postoperative anesthesia care unit
Intervention
Patients in the intervention group will be prepared for anesthesia and surgery, according standard of care. 60 minutes before the planned surgery the patient will receive xylomethazoline intranasally followed by a polyvinyl-alcohol (PVA) nasal dressing (Merocel®) in both nostrils. Merocel PVA is sponge-like material consisting of highly biocompatible synthetic material that can be used as hemostatic agent. When hydrated the material expands and provides a tamponade effect by applying light surface pressure with minimal discomfort for the patient. By decongesting the mucosa with xylomethazoline in combination with Merocel® we expect that the nasal cavity will expand, which facilitates the passage of the nasal tube. We expect that by dilating the nasal cavity will ensure an mechanically easier and less traumatic intubation.
Afdeling anesthesiologie
Catharina Ziekenhuis Eindhoven
Eindhoven
The Netherlands
arthur.bouwman@catharinaziekenhuis.nl
Afdeling anesthesiologie
Catharina Ziekenhuis Eindhoven
Eindhoven
The Netherlands
arthur.bouwman@catharinaziekenhuis.nl
Inclusion criteria
Age older than 18 years
Nasal intubation indicated and required for the planned surgery
Informed consent
Exclusion criteria
Age less than 18 years old
COPD Gold 3 or 4
Severe dyspnoe
(History of) nasal trauma or anatomical deformities
Known allergy to any of the medications used
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL4572 |
NTR-old | NTR4740 |
Other | NL4819.060.14 : ABR4819 |