Nasotracheal Intubation in Critically Ill.

Not Applicable

Recruiting

Interventions: Device: nasotracheal intubation
Device: orotracheal intubation

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
nasotracheal intubation	nasotracheal intubation	-
orotracheal intubation	orotracheal intubation	-

Primary Outcome Measures

Name	Time	Method
Sedation depth	intubation to 72 hours	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.

Secondary Outcome Measures

Name	Time	Method
time to extubation	intubation to day 30	time until airway device can be removed or patient receives tracheostomy
vasopressor therapy	intubation to day 10	doses of vasopressor drugs while on airway device
sinusitis	intubation to day 30	incidence of sinusitis associated with airway device
rate of extubation	intubation to day 30	rate of successful removal of airway device without tracheostomy
tracheostomy	intubation to day 30	rate of tracheostomy
sedative drugs	intubation to day 10	doses of sedative drugs therapy while on airway device
ventilator associated pneumonia	intubation to day 30	incidence of ventilator associated pneumonia associated with airway device
length of intensive care stay	intubation to day 30	length of intensive care stay
complications	intubation to day 1	complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)
mortality	intubation to day 30	mortality
Sedation depth	intubation to day 10	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.
spontaneous breathing	intubation to day 10	rate of spontaneous breathing while on airway device
physiotherapy	intubation to day 10	intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy

Locations (1): Universitätsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, HH, Germany