NaTra-P: Nasotracheal Intubation in Critically Ill.
Study Details
Study Description
Brief Summary
The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study:
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nasotracheal intubation
|
Device: nasotracheal intubation
patients requiring tracheal intubation receive nasotracheal intubation
Other Names:
|
| Active Comparator: orotracheal intubation
|
Device: orotracheal intubation
patients requiring tracheal intubation receive orotracheal intubation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- time to extubation [intubation to day 30]
time until airway device can be removed or patient receives tracheostomy
- rate of extubation [intubation to day 30]
rate of successful removal of airway device without tracheostomy
- tracheostomy [intubation to day 30]
rate of tracheostomy
- spontaneous breathing [intubation to day 10]
rate of spontaneous breathing while on airway device
- vasopressor therapy [intubation to day 10]
doses of vasopressor drugs while on airway device
- 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
- sinusitis [intubation to day 30]
incidence of sinusitis associated with 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18
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Patients requiring tracheal intubation during their intensive care stay.
Exclusion Criteria:
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orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway)
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tracheal intubation indicated for deep sedation (e.g. treatment of elevated intracranial pressure)
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thrombocytopenia < 50/nl or other risk factors for bleeding
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pregnant or breastfeeding women
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denial of consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | HH | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: Jörn Grensemann, MD, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NaTra-P