Nasotracheal Intubation in Critically Ill. (NaTra-P)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Tracheal Intubation Morbidity
• Intervention / Treatment: Device: nasotracheal intubation; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • HH
    • Hamburg, HH, Germany, 20246
      • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nasotracheal intubation	Device: nasotracheal intubation; patients requiring tracheal intubation receive nasotracheal intubation; Other Names: NTI
Active Comparator: orotracheal intubation	Device: orotracheal intubation; patients requiring tracheal intubation receive orotracheal intubation; Other Names: OTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Jörn Grensemann, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): November 8, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: critical care; airway management; tracheal intubation; nasotracheal intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NaTra-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No