Nasotracheal Intubation in Critically Ill. (NaTra-P)
Primary Purpose
Tracheal Intubation Morbidity, Critical Care
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
nasotracheal intubation
orotracheal intubation
Sponsored by
About this trial
This is an interventional treatment trial for Tracheal Intubation Morbidity focused on measuring tracheal intubation, airway management, critical care, nasotracheal intubation
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
Sites / Locations
- Universitätsklinikum Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nasotracheal intubation
orotracheal intubation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
time to extubation
time until airway device can be removed or patient receives tracheostomy
rate of extubation
rate of successful removal of airway device without tracheostomy
tracheostomy
rate of tracheostomy
spontaneous breathing
rate of spontaneous breathing while on airway device
vasopressor therapy
doses of vasopressor drugs while on airway device
sedative drugs
doses of sedative drugs therapy while on airway device
ventilator associated pneumonia
incidence of ventilator associated pneumonia associated with airway device
sinusitis
incidence of sinusitis associated with airway device
physiotherapy
intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy
length of intensive care stay
length of intensive care stay
complications
complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)
mortality
mortality
Full Information
NCT ID
NCT05780385
First Posted
March 5, 2023
Last Updated
March 20, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT05780385
Brief Title
Nasotracheal Intubation in Critically Ill.
Acronym
NaTra-P
Official Title
Nasotracheal Intubation vs. Conventional Airway Management in Critically Ill Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Intubation Morbidity, Critical Care
Keywords
tracheal intubation, airway management, critical care, nasotracheal intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nasotracheal intubation
Arm Type
Experimental
Arm Title
orotracheal intubation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
nasotracheal intubation
Other Intervention Name(s)
NTI
Intervention Description
patients requiring tracheal intubation receive nasotracheal intubation
Intervention Type
Device
Intervention Name(s)
orotracheal intubation
Other Intervention Name(s)
OTI
Intervention Description
patients requiring tracheal intubation receive orotracheal intubation
Primary Outcome Measure Information:
Title
Sedation depth
Description
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.
Time Frame
intubation to 72 hours
Secondary Outcome Measure Information:
Title
Sedation depth
Description
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.
Time Frame
intubation to day 10
Title
time to extubation
Description
time until airway device can be removed or patient receives tracheostomy
Time Frame
intubation to day 30
Title
rate of extubation
Description
rate of successful removal of airway device without tracheostomy
Time Frame
intubation to day 30
Title
tracheostomy
Description
rate of tracheostomy
Time Frame
intubation to day 30
Title
spontaneous breathing
Description
rate of spontaneous breathing while on airway device
Time Frame
intubation to day 10
Title
vasopressor therapy
Description
doses of vasopressor drugs while on airway device
Time Frame
intubation to day 10
Title
sedative drugs
Description
doses of sedative drugs therapy while on airway device
Time Frame
intubation to day 10
Title
ventilator associated pneumonia
Description
incidence of ventilator associated pneumonia associated with airway device
Time Frame
intubation to day 30
Title
sinusitis
Description
incidence of sinusitis associated with airway device
Time Frame
intubation to day 30
Title
physiotherapy
Description
intensive care unit mobility score (ICU-MS), Range 0 to 10 with higher values indicating higher extend of physiotherapy
Time Frame
intubation to day 10
Title
length of intensive care stay
Description
length of intensive care stay
Time Frame
intubation to day 30
Title
complications
Description
complications associated with intubation (i.e. bleeding, damage to teeth, aspiration)
Time Frame
intubation to day 1
Title
mortality
Description
mortality
Time Frame
intubation to day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pischtaz A Tariparast, MD
Phone
+49 40 7410 57010
Email
p.tariparast@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tim T Hardel, MD
Phone
+49 40 7410 57010
Email
t.hardel@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörn Grensemann, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kluge, MD, PhD
Phone
+49 40 7410
Ext
57010
Email
s.kluge@uke.de
12. IPD Sharing Statement
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Nasotracheal Intubation in Critically Ill.
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