Nasotracheal Intubation in Critically Ill.

Study Overview
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Brief Summary
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The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study: required sedation depth rate of spontaneous breathing extend and possibility of physiotherapy vasopressor and sedative drug doses Participants are randomized 1:1 to receive either nasotracheal or orotracheal intubation.

Detailed Description
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In the intensive care unit endotracheal intubation and consecutive mechanical ventilation are required for different surgical procedures, examinations and interventions in the ICU or due to respiratory insufficiency. Commonly, intubation is performed orotracheally by direct laryngoscopy after preoxygenation and administration of narcotics and a muscle relaxant. When using this technique sedation is often necessary for tolerance of the orotracheal tube. To avoid the adverse side effects of sedation and mechanical ventilation as for example hypotension, barotrauma, ventilator associated pneumonia, etc., intubation via a nasotracheal approach might be favorable. Retrospective data show that nasotracheal intubation is associated with fewer sedatives, vasopressors, and a higher rate of spontaneous breathing. As there is a paucity of data concerning the use of nasotracheal intubation in the intensive care setting the investigators aim to compare the use of orotracheal and nasotracheal tubes in a prospective randomized trial, using sedation depth as primary outcome measure.

Official Title
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Nasotracheal Intubation vs. Conventional Airway Management in Critically Ill Patients.

Conditions
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Tracheal Intubation Morbidity, Critical Care

Intervention / Treatment
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* Device: nasotracheal intubation
* Device: orotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Patients requiring tracheal intubation during their intensive care stay. Exclusion Criteria: orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway) tracheal intubation indicated for deep sedation (e.g. treatment of elevated intracranial pressure) thrombocytopenia < 50/nl or other risk factors for bleeding pregnant or breastfeeding women denial of consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasotracheal intubation<br> | Device: nasotracheal intubation<br>* patients requiring tracheal intubation receive nasotracheal intubation<br>* Other names: NTI;|
| Active Comparator: orotracheal intubation<br> | Device: orotracheal intubation<br>* patients requiring tracheal intubation receive orotracheal intubation<br>* Other names: OTI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation depth | fraction of time with a Richmond Agitation and Sedation Scale (RASS) of 0 or -1. Range -5 to +4 with 0 as optimum value representing awake and alert patient. | intubation to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation depth | fraction of time with Richmond Agitation and Sedation Scale (RASS) above and below targeted RASS of 0 or -1. Range -5 to +4 with 0 as optimum value representing awake and alert patient. | intubation to day 10 | 
| time to extubation | time until airway device can be removed or patient receives tracheostomy | intubation to day 30 | 
| rate of extubation | rate of successful removal of airway device without tracheostomy | intubation to day 30 | 
| tracheostomy | rate of tracheostomy | intubation to day 30 | 
| spontaneous breathing | rate of spontaneous breathing while on airway device | intubation to day 10 | 
| vasopressor therapy | doses of vasopressor drugs while on airway device | intubation to day 10 | 
| sedative drugs | doses of sedative drugs therapy while on airway device | intubation to day 10 | 
| ventilator associated pneumonia | incidence of ventilator associated pneumonia associated with airway device | intubation to day 30 | 
| sinusitis | incidence of sinusitis associated with airway device | intubation to day 30 | 
| physiotherapy | intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy | intubation to day 10 | 
| length of intensive care stay | length of intensive care stay | intubation to day 30 | 
| complications | complications associated with intubation (i.e. bleeding, damage to teeth, aspiration) | intubation to day 1 | 
| mortality | mortality | intubation to day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation, airway management, critical care, nasotracheal intubation