Nasotracheal Intubation Vs. Conventional Airway Management in Critically Ill Patients.

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country126 target enrollmentFebruary 10, 2023

ConditionsTracheal Intubation Morbidity Critical Care

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tracheal Intubation Morbidity
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 126
Locations: 1
Primary Endpoint: Sedation depth
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 10, 2023

End Date

November 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

Sedation depth

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.