Clinical trial NCT05780385: Nasotracheal Intubation in Critically Ill.
Official title: Nasotracheal Intubation Vs. Conventional Airway Management in Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation Morbidity
Critical Care
Keywords: tracheal intubation
airway management
critical care
nasotracheal intubation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sedation depth
timeFrame: intubation to 72 hours
Secondary outcomes:
measure: Sedation depth
timeFrame: intubation to day 10
measure: time to extubation
timeFrame: intubation to day 30
measure: rate of extubation
timeFrame: intubation to day 30
measure: tracheostomy
timeFrame: intubation to day 30
measure: spontaneous breathing
timeFrame: intubation to day 10
measure: vasopressor therapy
timeFrame: intubation to day 10
measure: sedative drugs
timeFrame: intubation to day 10
measure: ventilator associated pneumonia
timeFrame: intubation to day 30
measure: sinusitis
timeFrame: intubation to day 30
measure: physiotherapy
timeFrame: intubation to day 10
measure: length of intensive care stay
timeFrame: intubation to day 30
measure: complications
timeFrame: intubation to day 1
measure: mortality
timeFrame: intubation to day 30
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
state: HH
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jörn Grensemann, MD
role: PRINCIPAL_INVESTIGATOR
References: