Trial Outcomes & Findings for Novel Device to Assess Endotracheal Tube Migration (NCT NCT01697215)

Results Overview

Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.

Recruitment status

COMPLETED

Target enrollment

42 participants

Primary outcome timeframe

24 hours

Results posted on

2025-05-14

Participant Flow

During the study period, 42 patients were enrolled. Subjects had the AirWave system placed within 24 hours of endotracheal intubation. A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study.

Inclusion Criteria: subjects were eligible for the study if they met all of the following criteria: (1) age \> 18 years old; (2) oral endotracheal intubation within 24 hours of recruitment; (3) expected duration of mechanical ventilation \> 24 hours; (4) ETT internal diameter sizes from 6.5 to 9.0 mm. Exclusion criteria: subjects were excluded from participation if (1) ventilated through a tracheostomy, (2) unable to obtain consent, or (3) pregnancy.

Participant milestones

Participant milestones
Measure	Oral or Nasal Endotracheal Intubation Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. AirWave Migration at 24 hours as determined by (a) portable CXR (n = 28) was -0.06 (±1.3) cm with range of -3.5 and +3 cm, (b) ETT distance at the lips (n = 38) was -0.29 (±0.93) with a range of -2 to +3, and (c) the AirWave system (n = 27) was 0.39 (±1.5) with a range of -3 to +4 cm. Diverse reasons (Fig. 2) reduced the total number of patients in whom these three techniques can be compared.
Overall Study STARTED	42
Overall Study Migration at 24 hs by CXR	28
Overall Study ETT Distance at the Lips	38
Overall Study Airwave System	27
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral or Nasal Endotracheal Intubation Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. AirWave Migration at 24 hours as determined by (a) portable CXR (n = 28) was -0.06 (±1.3) cm with range of -3.5 and +3 cm, (b) ETT distance at the lips (n = 38) was -0.29 (±0.93) with a range of -2 to +3, and (c) the AirWave system (n = 27) was 0.39 (±1.5) with a range of -3 to +4 cm. Diverse reasons (Fig. 2) reduced the total number of patients in whom these three techniques can be compared.
Overall Study Physician Decision	5
Overall Study Malfunction	9
Overall Study CXR not available	9

Baseline Characteristics

Novel Device to Assess Endotracheal Tube Migration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(ETT) Migration During Routine Care Among Critically Ill Patients n=42 Participants A total of 42 patients (age: 61 \[SD ±13\] years, men: 52%) were recruited. A total of 19 patients had measurements of ETT migration at 24 hours by the 3 methodologies used in this study.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Age, Continuous	61 years STANDARD_DEVIATION 13 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	22 Participants n=93 Participants
Region of Enrollment United States	42 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study.

Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.

Outcome measures

Outcome measures
Measure	Oral or Nasal Endotracheal Intubation n=42 Participants Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. AirWave
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR Migration measured by CXR	-0.06 cm Standard Deviation 1.3
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR Migration measured by EET lip distance	-0.29 cm Standard Deviation 0.93
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR Migration measured by AirWave System	0.39 cm Standard Deviation 1.5

Adverse Events

Oral or Nasal Endotracheal 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

Adriano Tonelli, MD

Cleveland Clinic Foundation

Phone: 216-444-0812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place