Trial Outcomes & Findings for Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients (NCT NCT03779984)

Results Overview

The number of participants with nasal bleeding within 5 minutes following nasal tube placement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

Within 5 minutes following the nasal tracheal intubation

Results posted on

2024-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Red Rubber Catheter Group 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. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance	Standard Nasal Tracheal Intubation The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance
Overall Study STARTED	56	56
Overall Study COMPLETED	56	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Red Rubber Catheter Group n=56 Participants 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. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance	Standard Nasal Tracheal Intubation n=56 Participants The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance	Total n=112 Participants Total of all reporting groups
Age, Continuous	57.37 years STANDARD_DEVIATION 16.50 • n=56 Participants	56.75 years STANDARD_DEVIATION 16.26 • n=56 Participants	57.06 years STANDARD_DEVIATION 16.31 • n=112 Participants
Sex: Female, Male Female	21 Participants n=56 Participants	22 Participants n=56 Participants	43 Participants n=112 Participants
Sex: Female, Male Male	35 Participants n=56 Participants	34 Participants n=56 Participants	69 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	56 participants n=56 Participants	56 participants n=56 Participants	112 participants n=112 Participants
Body Mass Index (BMI)	27.28 Kg/m2 STANDARD_DEVIATION 5.01 • n=56 Participants	26.33 Kg/m2 STANDARD_DEVIATION 4.90 • n=56 Participants	26.81 Kg/m2 STANDARD_DEVIATION 4.95 • n=112 Participants

PRIMARY outcome

Timeframe: Within 5 minutes following the nasal tracheal intubation

The number of participants with nasal bleeding within 5 minutes following nasal tube placement.

Outcome measures

Outcome measures
Measure	Red Rubber Catheter Group n=56 Participants 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. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance	Standard Nasal Tracheal Intubation n=56 Participants The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance
The Number of Participants With Nasal Bleeding	22 Participants	35 Participants

SECONDARY outcome

Timeframe: Within 5 minutes following nasal intubation

Population: The number of patients with severe epistaxis in the use of the red rubber catheter vs. the standard insertion catheter

The number of participants with severe epistaxis within 5 minutes following nasal tube placement.

Outcome measures

Outcome measures
Measure	Red Rubber Catheter Group n=56 Participants 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. Red Rubber Catheter: Experimental group will be intubated with red rubber catheter guidance	Standard Nasal Tracheal Intubation n=56 Participants The nasotracheal tube will be inserted into the nasal passage. Standard nasal tracheal Intubation: Control group will be intubated with standard nasal tracheal tube without guidance
The Number of Participants With Severe Epistaxis	1 Participants	1 Participants

Adverse Events

Red Rubber Catheter Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Nasal Tracheal Intubation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Mercier

UTexasSouthwestern

Phone: 214-645-3479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place