Nasotracheal Intubation in Critically Ill.

NCT ID: NCT05780385

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2024-11-08

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.

Conditions

Tracheal Intubation Morbidity; Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

nasotracheal intubation

Group Type: EXPERIMENTAL

nasotracheal intubation

Intervention Type: DEVICE

patients requiring tracheal intubation receive nasotracheal intubation

orotracheal intubation

Group Type: ACTIVE_COMPARATOR

orotracheal intubation

Intervention Type: DEVICE

patients requiring tracheal intubation receive orotracheal intubation

Interventions

nasotracheal intubation

patients requiring tracheal intubation receive nasotracheal intubation

Intervention Type: DEVICE

orotracheal intubation

patients requiring tracheal intubation receive orotracheal intubation

Intervention Type: DEVICE

Other Intervention Names

NTI; OTI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörn Grensemann, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

Other Identifiers

NaTra-P

Identifier Type: -

Identifier Source: org_study_id