Nasotracheal Intubation in Critically Ill.

Critical Care Clinical Trial

— NaTra-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780385
• Other study ID #: NaTra-P
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Pischtaz A Tariparast, MD
• Phone: +49 40 7410 57010
• Email: p.tariparast[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Tracheal Intubation Morbidity

Intervention

Device:
• nasotracheal intubation
patients requiring tracheal intubation receive nasotracheal intubation
• orotracheal intubation
patients requiring tracheal intubation receive orotracheal intubation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg	HH

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation depth	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.	intubation to 72 hours
Secondary	Sedation depth	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.	intubation to day 10
Secondary	time to extubation	time until airway device can be removed or patient receives tracheostomy	intubation to day 30
Secondary	rate of extubation	rate of successful removal of airway device without tracheostomy	intubation to day 30
Secondary	tracheostomy	rate of tracheostomy	intubation to day 30
Secondary	spontaneous breathing	rate of spontaneous breathing while on airway device	intubation to day 10
Secondary	vasopressor therapy	doses of vasopressor drugs while on airway device	intubation to day 10
Secondary	sedative drugs	doses of sedative drugs therapy while on airway device	intubation to day 10
Secondary	ventilator associated pneumonia	incidence of ventilator associated pneumonia associated with airway device	intubation to day 30
Secondary	sinusitis	incidence of sinusitis associated with airway device	intubation to day 30
Secondary	physiotherapy	intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy	intubation to day 10
Secondary	length of intensive care stay	length of intensive care stay	intubation to day 30
Secondary	complications	complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)	intubation to day 1
Secondary	mortality	mortality	intubation to day 30