Nasotracheal Intubation in Critically Ill. (NaTra-P)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Critical Care; Tracheal Intubation Morbidity

Treatments: Device: nasotracheal intubation; Device: orotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT05780385

NaTra-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

nasotracheal intubation

Experimental group

Treatment:

Device: nasotracheal intubation

orotracheal intubation

Active Comparator group

Treatment:

Device: orotracheal intubation