Nasotracheal Intubation in Critically Ill.

NCT05780385 | Completed

• 1 other identifier: NaTra-P
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Intubation Morbidity; Critical Care

Keywords

tracheal intubation; airway management; critical care; nasotracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Sedation depth

  intubation to day 10

• time to extubation

  intubation to day 30

• rate of extubation

  intubation to day 30

• tracheostomy

  intubation to day 30

• spontaneous breathing

  intubation to day 10

Study Arms (2)

nasotracheal intubation

EXPERIMENTAL

Device: nasotracheal intubation

orotracheal intubation

ACTIVE COMPARATOR

Device: orotracheal intubation

Interventions

nasotracheal intubation DEVICE

patients requiring tracheal intubation receive nasotracheal intubation

Also known as: NTI

nasotracheal intubation

orotracheal intubation DEVICE

patients requiring tracheal intubation receive orotracheal intubation

Also known as: OTI

orotracheal intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Patients requiring tracheal intubation during their intensive care stay.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Study Officials

• Jörn Grensemann, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 22, 2023
• Study Start: February 10, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

DE (1)