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Completed

NCT Number: NCT05780385

Nasotracheal Intubation in Critically Ill.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasotracheal intubation

Device

patients requiring tracheal intubation receive nasotracheal intubation

Other names: NTI

orotracheal intubation

Device

patients requiring tracheal intubation receive orotracheal intubation

Other names: OTI

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sedation depth

    Time frame: intubation to day 10

    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.

  2. time to extubation

    Time frame: intubation to day 30

    time until airway device can be removed or patient receives tracheostomy

  3. rate of extubation

    Time frame: intubation to day 30

    rate of successful removal of airway device without tracheostomy

  4. tracheostomy

    Time frame: intubation to day 30

    rate of tracheostomy

  5. spontaneous breathing

    Time frame: intubation to day 10

    rate of spontaneous breathing while on airway device

  6. vasopressor therapy

    Time frame: intubation to day 10

    doses of vasopressor drugs while on airway device

  7. sedative drugs

    Time frame: intubation to day 10

    doses of sedative drugs therapy while on airway device

  8. ventilator associated pneumonia

    Time frame: intubation to day 30

    incidence of ventilator associated pneumonia associated with airway device

  9. sinusitis

    Time frame: intubation to day 30

    incidence of sinusitis associated with airway device

  10. physiotherapy

    Time frame: intubation to day 10

    intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy

  11. length of intensive care stay

    Time frame: intubation to day 30

    length of intensive care stay

  12. complications

    Time frame: intubation to day 1

    complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)

  13. mortality

    Time frame: intubation to day 30

    mortality

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: NaTra-P

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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