Intubation;DifficultNCT03779984
Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients
A study testing Red Rubber Catheter and Standard nasal tracheal Intubation in people with Intubation;Difficult, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Red Rubber Catheter and Standard nasal tracheal Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2019to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18, male and female
- Subjects undergoing surgery requiring NTI
- ASA 1-3
Who cannot join
- History of anticoagulant use or coagulopathy
- History of latex allergy
- History of difficult airway
- Anticipated difficult airway requiring awake intubation
- Abnormal anatomy of the nasal passage (due to prior trauma, surgery, congenital defects, etc.) or basilar skull fracture
- Patients unable to be placed in the sniffing position
Show all 9Show fewer
- Morbid obesity with BMI > 40
- Pregnancy
- ASA 4
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Heath Hospital System
Dallas, Texas, 75390
MD Anderson Center
Houston, Texas, 77030
About this study
Official title: Use of a Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients: A Prospective Randomized Controlled Trial
This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. This study will assess if the red-rubber catheter method leads to lower incidence and severity of epistaxis, faster time to intubation, and higher patient satisfaction compared to the current standard of care.
Read the detailed description
The study population for this prospective randomized controlled trial will consist of male and female adult subjects over the age of 18 having surgery requiring nasal tracheal intubation (NTI). Subjects will be randomized to either the Red Rubber Catheter (RRC) group or control group.
Oxymetazoline nasal spray will be administered with 1 spray per nostril preoperatively. Premedication with glycopyrrolate 0.2 mg and benzodiazepine at discretion of provider will be given preoperatively. Subjects will then be brought into the operating room and placed on all standard ASA monitors (BP cuff, EKG, pulse oximetry). One spray of oxymetazoline per nostril will again be administered. Standard preoxygenation will be used with a face mask and 100% O2. After induction of anesthesia, provider will confirm mask ventilation and 1 more spray of oxymetazoline will be administered per nostril. Intubation will first be attempted via a naris. Size 6.5 nasotracheal RAE tubes (Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, manufactured by Coviden llc, Mansfield, MA 02048) will be used in female patients and size 7.5 in males. The tubes will be thermosoftened by allowing them to sit in warm saline prior to use. Water-based lubrication will be used for dilation and intubation. Time from insertion of RRC or NETT into nasal passage to first recording of end-tidal CO2 will be recorded. Direct video laryngoscopy will be used to facilitate placement of the nasotracheal RAE tube.
Five minutes after intubation, a non-collaborating anesthesia provider blinded to the method of intubation will grade the severity of bleeding by performing direct video laryngoscopy, inspecting the posterior pharynx and using a scale -
- No epistaxis (no blood observed on either the surface of the tube or the posterior pharyngeal wall);
- Mild epistaxis (blood apparent on the surface of the tube or posterior pharyngeal wall);
- Moderate epistaxis (pooling of blood on the posterior pharyngeal wall);
- Severe epistaxis (a large amount of blood in the pharynx impeding nasotracheal intubation-before the epistaxis assessor enters the operating room, requiring suction for intubation or necessitating urgent orotracheal intubation.)
Degree of patient satisfaction and nasal pain on the side of intubation will be rated on a numerical rating scale at 30 and 60 minutes in the post-anesthesia care unit.
- Conditions
- Intubation;Difficult
- Being tested
- Red Rubber Catheter, Standard nasal tracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Rubber CatheterDevice
Experimental group will be intubated with red rubber catheter guidance
Standard nasal tracheal IntubationDevice
Also called Nasal tracheal intubation without guidance
Control group will be intubated with standard nasal tracheal tube without guidance
| Study group | Role | What they receive |
|---|---|---|
| Red Rubber Catheter Group | Experimental | Red Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. Receives: Device: Red Rubber Catheter |
| Standard nasal tracheal intubation | Sham comparator | The nasotracheal tube will be inserted into the nasal passage. Receives: Device: Standard nasal tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Nasal Bleeding
The number of participants with nasal bleeding within 5 minutes following nasal tube placement.
Measured: Within 5 minutes following the nasal tracheal intubation
Secondary outcomes (1)
The Number of Participants With Severe Epistaxis
The number of participants with severe epistaxis within 5 minutes following nasal tube placement.
Measured: Within 5 minutes following nasal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start31 May 2019
- Primary completion6 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, David W Mercier, University of Texas Southwestern Medical Center
- Investigators
- Christina Riccio, MD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779984
- Sponsor's protocol ID
- STU-2018-0190
- Status last verified
- Oct 2024
- First submitted
- 13 Dec 2018
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03779984
- Acronym / sponsor ID
- STU-2018-0190
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 31 May 2019 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. This study will assess if the red-rubber catheter method leads to lower incidence and severity of epistaxis, faster time to intubation, and higher patient satisfaction compared to the current standard of care.
Detailed description
The study population for this prospective randomized controlled trial will consist of male and female adult subjects over the age of 18 having surgery requiring nasal tracheal intubation (NTI). Subjects will be randomized to either the Red Rubber Catheter (RRC) group or control group.
Oxymetazoline nasal spray will be administered with 1 spray per nostril preoperatively. Premedication with glycopyrrolate 0.2 mg and benzodiazepine at discretion of provider will be given preoperatively. Subjects will then be brought into the operating room and placed on all standard ASA monitors (BP cuff, EKG, pulse oximetry). One spray of oxymetazoline per nostril will again be administered. Standard preoxygenation will be used with a face mask and 100% O2. After induction of anesthesia, provider will confirm mask ventilation and 1 more spray of oxymetazoline will be administered per nostril. Intubation will first be attempted via a naris. Size 6.5 nasotracheal RAE tubes (Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, manufactured by Coviden llc, Mansfield, MA 02048) will be used in female patients and size 7.5 in males. The tubes will be thermosoftened by allowing them to sit in warm saline prior to use. Water-based lubrication will be used for dilation and intubation. Time from insertion of RRC or NETT into nasal passage to first recording of end-tidal CO2 will be recorded. Direct video laryngoscopy will be used to facilitate placement of the nasotracheal RAE tube.
Five minutes after intubation, a non-collaborating anesthesia provider blinded to the method of intubation will grade the severity of bleeding by performing direct video laryngoscopy, inspecting the posterior pharynx and using a scale -
- No epistaxis (no blood observed on either the surface of the tube or the posterior pharyngeal wall);
- Mild epistaxis (blood apparent on the surface of the tube or posterior pharyngeal wall);
- Moderate epistaxis (pooling of blood on the posterior pharyngeal wall);
- Severe epistaxis (a large amount of blood in the pharynx impeding nasotracheal intubation-before the epistaxis assessor enters the operating room, requiring suction for intubation or necessitating urgent orotracheal intubation.)
Degree of patient satisfaction and nasal pain on the side of intubation will be rated on a numerical rating scale at 30 and 60 minutes in the post-anesthesia care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Rubber Catheter Group | Experimental | Device: Red Rubber CatheterRed Rubber Catheter (RRC) guided nasal tracheal intubation; a RRC securely attached to nasal tracheal tube and the rounded end of the catheter introduced into a naris. |
| Standard nasal tracheal intubation | Sham comparator | Device: Standard nasal tracheal IntubationThe nasotracheal tube will be inserted into the nasal passage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18, male and female
- Subjects undergoing surgery requiring NTI
- ASA 1-3
Key exclusion criteria (9 listed)
- History of anticoagulant use or coagulopathy
- History of latex allergy
- History of difficult airway
- Anticipated difficult airway requiring awake intubation
- Abnormal anatomy of the nasal passage (due to prior trauma, surgery, congenital defects, etc.) or basilar skull fracture
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 |
|---|---|---|
| Red Rubber CatheterExperimental group will be intubated with red rubber catheter guidance | Device | Red Rubber Catheter Group |
| Standard nasal tracheal IntubationAlso: Nasal tracheal intubation without guidanceControl group will be intubated with standard nasal tracheal tube without guidance | Device | Standard nasal tracheal intubation |
Primary outcome
The Number of Participants With Nasal Bleeding
Time frame: Within 5 minutes following the nasal tracheal intubation
The number of participants with nasal bleeding within 5 minutes following nasal tube placement.
1 secondary outcome
The Number of Participants With Severe Epistaxis
Time frame: Within 5 minutes following nasal intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christina Riccio, MD study director
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Rubber Catheter and Standard nasal tracheal Intubation in people with Intubation;Difficult, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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 3 inclusion and 9 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With Nasal Bleeding (time frame: Within 5 minutes following the nasal tracheal intubation). 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 21 Nov 2024.