Trial Outcomes & Findings for Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients (NCT NCT00901485)

NCT ID: NCT00901485

Last Updated: 2021-06-18

Results Overview

Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2021-06-18

Participant Flow

Participant milestones

Measure	AutoVPAP Then VPAPIIIST-A All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation	VPAPIIIST-A First, Then AutoVPAP All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation
Overall Study STARTED	10	13
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	AutoVPAP Then VPAPIIIST-A All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation	VPAPIIIST-A First, Then AutoVPAP All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients

Baseline characteristics by cohort

Measure	All Patients n=23 Participants Patients underwent a cross over study design. In a randomised order they used 1 month of domiciliary nocturnal autotitrating, intelligent volume assured pressure support (iVAPS) non-invasive ventilation, and one month of standard non-invasive ventilation
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
FEV1 (forced expiratory volume) (L)	1.5 L n=5 Participants
FVC (forced vital capacity)	1.9 L n=5 Participants
FEV1/FVC	0.75 ratio n=5 Participants
maximal inspiratory effort (MIP) (cmH2O)	50 cmH2O n=5 Participants
Maximum expiratory pressure (MEP)	118 cmH2O n=5 Participants
sniff nasal inspiratory pressure (SNIP)	39 cmH2O n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

Outcome measures

Measure	Autotitrating iVAPS NIV n=18 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=18 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Overnight Mean Oxygen Saturation	96 % SaO2 Interval 95.0 to 98.0	96 % SaO2 Interval 93.0 to 97.0

SECONDARY outcome

Timeframe: 4 weeks

Population: All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis

Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

Outcome measures

Measure	Autotitrating iVAPS NIV n=18 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=18 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Overnight Mean Transcutaneous Carbon Dioxide	6.5 kPa Interval 5.8 to 6.8	6.2 kPa Interval 5.8 to 6.9

SECONDARY outcome

Timeframe: 4 weeks

Population: All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis

Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

Outcome measures

Measure	Autotitrating iVAPS NIV n=18 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=18 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Overnight Peak Transcutaneous Carbon Dioxide	7.1 kPa Interval 6.3 to 7.6	6.9 kPa Interval 6.3 to 7.5

SECONDARY outcome

Timeframe: 4 weeks

Population: All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis

Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by >4%.

Outcome measures

Measure	Autotitrating iVAPS NIV n=18 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=18 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Oxygen Desaturation Index (>4%)	2.5 events/hr Interval 1.3 to 12.2	5.0 events/hr Interval 1.5 to 11.6

SECONDARY outcome

Timeframe: 4 weeks

Population: 16 patients had comparative PSG data with all signals present for their sleep studies on both ventilator modes.

A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ).

Sleep quality was assessed by the Arousal Index (no of arousals/hour)

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Sleep Quality: Arousal Index	17 events/hour Interval 8.0 to 24.0	14 events/hour Interval 10.0 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 1 participant had missing adherence data and so was excluded from this analysis

Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).

Outcome measures

Measure	Autotitrating iVAPS NIV n=17 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=17 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Ventilator Adherence	5.40 hh:mm/day Interval 4.42 to 6.49	4.20 hh:mm/day Interval 2.27 to 6.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing values from one of the ventilator modes, thus were excluded from the analysis

Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Median Overnight Minute Ventilation	6.8 L/min Interval 5.3 to 8.3	6.2 L/min Interval 5.4 to 9.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data from one of the ventialtory modes and were excluded from the analysis

Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Median Overnight Pressure Support	8.3 cmH2O Interval 5.6 to 10.4	10.0 cmH2O Interval 9.0 to 11.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data from one of the ventilatory modes and so were excluded

Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Median Overnight Tidal Volume	421 ml Interval 321.0 to 521.0	400 ml Interval 300.0 to 575.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data from one ventilatory mode and thus were excluded from analysis

Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Median Overnight Respiratory Rated	16.7 bpm Interval 13.2 to 18.4	15.5 bpm Interval 13.5 to 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data and thus were excluded from analysis

Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Subjective Ventilator Tolerance: Comfort of Breath Delivered	73 units on a scale Interval 55.0 to 91.0	72 units on a scale Interval 45.0 to 85.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data and so were excluded from analysis

Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Subjective Ventilator Tolerance: Ease of Falling Asleep	86 units on a scale Interval 69.0 to 94.0	79 units on a scale Interval 60.0 to 89.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data and were thus excluded from analysis

Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Subjective Ventilation Tolerance: Ease of Use of Ventilator	90 units on a scale Interval 77.0 to 95.0	86 units on a scale Interval 78.0 to 98.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: 2 patients had missing data, thus were excluded from analysis

Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)

Outcome measures

Measure	Autotitrating iVAPS NIV n=16 Participants AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy.	Standard Non-invasive PS Ventilation n=16 Participants VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
Subjective Ventilator Tolerance: Liked Using Ventilator	81 units on a scale Interval 55.0 to 94.0	68 units on a scale Interval 24.0 to 79.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)

Outcome measures

Outcome data not reported

Adverse Events

Autotitrating iVAPS NIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Non-invasive PS Ventilation

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

Miss Julia Kelly

Royal Brompton Hospital

Phone: +44 2073528121

Email: j.kelly@rbht.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place