Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
NCT Number: NCT05780385
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients requiring tracheal intubation receive nasotracheal intubation
Other names: NTI
patients requiring tracheal intubation receive orotracheal intubation
Other names: OTI
Time frame: 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.
Time frame: 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 frame: intubation to day 30
time until airway device can be removed or patient receives tracheostomy
Time frame: intubation to day 30
rate of successful removal of airway device without tracheostomy
Time frame: intubation to day 30
rate of tracheostomy
Time frame: intubation to day 10
rate of spontaneous breathing while on airway device
Time frame: intubation to day 10
doses of vasopressor drugs while on airway device
Time frame: intubation to day 10
doses of sedative drugs therapy while on airway device
Time frame: intubation to day 30
incidence of ventilator associated pneumonia associated with airway device
Time frame: intubation to day 30
incidence of sinusitis associated with airway device
Time frame: intubation to day 10
intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy
Time frame: intubation to day 30
length of intensive care stay
Time frame: intubation to day 1
complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)
Time frame: intubation to day 30
mortality
Universitätsklinikum Hamburg-Eppendorf
Other
Nasotracheal Intubation Vs. Conventional Airway Management in Critically Ill Patients.
Acronym: NaTra-P
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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