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Decongestiva (neusontzwellers) voor het ontzwellen van de neusholte, om schade aan het neusslijmvlies en neusbloedingen bij intubatie door de neus te voorkomen


- candidate number19297
- NTR NumberNTR4740
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2014
- Secondary IDsABR4819 NL4819.060.14
- Public TitleDecongestiva (neusontzwellers) voor het ontzwellen van de neusholte, om schade aan het neusslijmvlies en neusbloedingen bij intubatie door de neus te voorkomen
- Scientific TitleDecongestants for dilating the nasal cavity, a randomised, blinded, prospective study to prevent iatrogenic epistaxis during nasotracheal intubation
- ACRONYM
- hypothesisNasotracheal 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.
- Healt Condition(s) or Problem(s) studiedEpistaxis, Nasal intubation
- Inclusion criteriaAge older than 18 years
Nasal intubation indicated and required for the planned surgery
Informed consent
- Exclusion criteriaAge 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-aug-2014
- planned closingdate1-aug-2015
- Target number of participants180
- InterventionsPatients 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.
- 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
- Timepoints- during nasal intubation
- after intubation
- during postoperative recovery the postoperative anesthesia care unit
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R.A. Bouwman
- CONTACT for SCIENTIFIC QUERIESDr. R.A. Bouwman
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD13-aug-2014 - 3-sep-2014


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