Tracheal Intubation MorbidityNaTra-PNCT05780385
Nasotracheal Intubation in Critically Ill.
A study testing nasotracheal intubation and orotracheal intubation in people with Tracheal Intubation Morbidity and Critical Care, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation Morbidity, Critical Care
- What is being tested?
- nasotracheal intubation and orotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2023to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patients requiring tracheal intubation during their intensive care stay.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: 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.
Read the 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
- Being tested
- nasotracheal intubation, orotracheal intubation
- Keywords
- tracheal intubation, airway management, critical care, nasotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasotracheal intubationDevice
Also called NTI
patients requiring tracheal intubation receive nasotracheal intubation
orotracheal intubationDevice
Also called OTI
patients requiring tracheal intubation receive orotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| nasotracheal intubation | Experimental | Not described Receives: Device: nasotracheal intubation |
| orotracheal intubation | Active comparator | Not described Receives: Device: orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intubation to 72 hours
Secondary outcomes (13)
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.
Measured: intubation to day 10
time to extubation
time until airway device can be removed or patient receives tracheostomy
Measured: intubation to day 30
rate of extubation
rate of successful removal of airway device without tracheostomy
Measured: intubation to day 30
tracheostomy
rate of tracheostomy
Measured: intubation to day 30
spontaneous breathing
rate of spontaneous breathing while on airway device
Measured: intubation to day 10
vasopressor therapy
doses of vasopressor drugs while on airway device
Measured: intubation to day 10
sedative drugs
doses of sedative drugs therapy while on airway device
Measured: intubation to day 10
ventilator associated pneumonia
incidence of ventilator associated pneumonia associated with airway device
Measured: intubation to day 30
sinusitis
incidence of sinusitis associated with airway device
Measured: intubation to day 30
physiotherapy
intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy
Measured: intubation to day 10
length of intensive care stay
length of intensive care stay
Measured: intubation to day 30
complications
complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)
Measured: intubation to day 1
mortality
mortality
Measured: intubation to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start10 Feb 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn Grensemann, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780385
- Sponsor's protocol ID
- NaTra-P
- Acronym
- NaTra-P
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation Vs. Conventional Airway Management in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT05780385
- Acronym / sponsor ID
- NaTra-P / NaTra-P
- Conditions
- Tracheal Intubation Morbidity, Critical Care
- Keywords
- tracheal intubation, airway management, critical care, nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasotracheal intubation | Experimental | Device: nasotracheal intubation |
| orotracheal intubation | Active comparator | Device: orotracheal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Patients requiring tracheal intubation during their intensive care stay.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasotracheal intubationAlso: NTIpatients requiring tracheal intubation receive nasotracheal intubation | Device | nasotracheal intubation |
| orotracheal intubationAlso: OTIpatients requiring tracheal intubation receive orotracheal intubation | Device | orotracheal intubation |
Primary outcome
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.
13 secondary outcomes
Sedation depth
Time frame: intubation to day 10
time to extubation
Time frame: intubation to day 30
rate of extubation
Time frame: intubation to day 30
tracheostomy
Time frame: intubation to day 30
spontaneous breathing
Time frame: intubation to day 10
vasopressor therapy
Time frame: intubation to day 10
sedative drugs
Time frame: intubation to day 10
ventilator associated pneumonia
Time frame: intubation to day 30
sinusitis
Time frame: intubation to day 30
physiotherapy
Time frame: intubation to day 10
length of intensive care stay
Time frame: intubation to day 30
complications
Time frame: intubation to day 1
mortality
Time frame: intubation to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Related trials for Tracheal Intubation Morbidity
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Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörn Grensemann, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasotracheal intubation and orotracheal intubation in people with Tracheal Intubation Morbidity and Critical Care, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation depth (time frame: intubation to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.