EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated... | NCT04400643

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INTELLiVENT-ASV	Experimental	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation.	Device: INTELLiVENT-ASV
Non-Automated ventilation	Active Comparator	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	Device: Non-automated ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INTELLiVENT-ASV	Device	INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy Measured as Percentage of Time Spent in Optimal Range	Objective of this study is to compare the efficacy of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of efficacy. Efficacy endpoints are composite endpoints & are based on six variables that will be continuously recorded during the study period: These 6 variables: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as optimal when all six variables were within predefined optimal ranges	up to 7 days after enrollment
Safety Measured as Percentage of Time Spent in Sub-optimal Range	Objective of this study is to compare the safety of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of safety. Safety endpoints are composite endpoints & are based on six variables that will be continuously recorded during the study period: sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as sub-optimal when at least one of the six variables was within predefined sub-optimal ranges.	7 days after enrollment.

Secondary Outcomes

Measure	Description	Time Frame
Fraction of Inspiration Oxygen (FiO2) (%)	FiO2 was measured breath-by-breath for all the study periods.	up to 28 days after enrollment
Expiratory Time Constant (s)	Expiratory time constant was calculated breath-by-breath as the ratio of volume divided by flow at 75% of the expired volume.

Other Outcomes

Measure	Description	Time Frame
Mortality at 28 Days (n (%))		up to 28 days after enrollment
Duration Invasive Mechanical Ventilation (Days)	Mechanical ventilation duration was recorded from the date of intubation to the date of last extubation or death if the patient died while still intubated.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar Universitário de Lisboa Central		Lisbon		1150-199	Portugal

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 2, 2020	May 3, 2024

Arm/Group Information

ID	Title	Description
BG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
BG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00031 BG00131 BG00262

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	OG00028(19 to 37) OG00129(8 to 39)

Primary

Safety Measured as Percentage of Time Spent in Sub-optimal Range

Objective of this study is to compare the safety of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of safety. Safety endpoints are composite endpoints & are based on six variables that will be continuously recorded during the study period: sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as sub-optimal when at least one of the six variables was within predefined sub-optimal ranges.

Posted

Median

Inter-Quartile Range

percentage of time in sub-optimal range

7 days after enrollment.

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Secondary

Fraction of Inspiration Oxygen (FiO2) (%)

FiO2 was measured breath-by-breath for all the study periods.

Posted

Median

Inter-Quartile Range

percentage of inspired oxygen

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Expiratory Time Constant (s)

Expiratory time constant was calculated breath-by-breath as the ratio of volume divided by flow at 75% of the expired volume.

Posted

Median

Inter-Quartile Range

second (s)

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Positive End-Expiratory Pressure (PEEP) (cm H2O)

PEEP was measured breath-by-breath for all the study period.

Posted

Median

Inter-Quartile Range

Cm H2O

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Tidal Volume (ml)

Tidal volume was measured breath-by-breath for all the study period.

Posted

Median

Inter-Quartile Range

milliliter (ml)

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Tidal Volume mL/kg Ideal Body Weight (IBW)

Tidal volume mL/kg ideal body weight (IBW) will be assessed automatically breath-by-breath

Posted

Median

Inter-Quartile Range

ml/kg of ideal body weight (IBW)

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Ventilation - Respiratory Rate

Respiratory rate was measured breath-by-breath for all the study period.

Posted

Median

Inter-Quartile Range

breath/min

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Secondary

Numbers of Manual Settings Changes Per Day

The total number of automatic setting changes was recorded during the study period. Automatic settings included inspiratory pressure, pressure support, respiratory rate, PEEP, and inspired oxygen fraction.

Posted

Median

Inter-Quartile Range

manual setting changes per day

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants

Secondary

Automatic Settings Changes Per Day

Posted

Median

Inter-Quartile Range

automatic setting changes per day

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants

Other Pre-specified

Mortality at 28 Days (n (%))

Posted

Count of Participants

Participants

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Other Pre-specified

Duration Invasive Mechanical Ventilation (Days)

Mechanical ventilation duration was recorded from the date of intubation to the date of last extubation or death if the patient died while still intubated.

Posted

Median

Inter-Quartile Range

days

up to 28 days from enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants

Other Pre-specified

Passive Ventilation Duration (h)

Passive ventilation is defined when the percentage of subject's triggered breath is lower than 25% of total respiratory rate.

Posted

Median

Inter-Quartile Range

hours (h)

up to 28 days from enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants

Other Pre-specified

Ventilator Free Days at Day 28 (d)

Posted

Median

Inter-Quartile Range

days

up to 28 days from enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Time in Allocated Mode (%)

The percentage of time in the allocated mode was calculated breath-by-breath according to the ventilation mode used.

Posted

Median

Inter-Quartile Range

percentage

up to 28 days after enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units	Counts
Participants

Other Pre-specified

Efficacy Measured as Percentage of Time Spent in Optimal Range

Percentage of time spent in optimal range was calculated breath-by-breath during all the study period. Breath were classified as optimal when all six variables were in predefined optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.

Posted

Median

Inter-Quartile Range

percentage of time in optimal ranges

up to 28 days from enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units

Other Pre-specified

Safety Measured as Percentage of Time Spent in Sub-optimal Range

Percentage of time spent in sub-optimal range was calculated breath-by-breath during all the study period. Breath were classified as sub-optimal when at least one variable was in predefined sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.

Posted

Median

Inter-Quartile Range

percentage of time in sub-optimal ranges

up to 28 days from enrollment

ID	Title	Description
OG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
OG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Units

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	INTELLiVENT-ASV	INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation. INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.	7	31	6	31	2	31
EG001	Non-Automated Ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	11	31	5	31	4	31

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ACCIDENTAL EXTUBATION BY THE PATIENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
Asystole	Cardiac disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0013 events3 affected31 at risk
Cecum perforation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
HEMODYNAMIC INSTABILITY IN THE CONTEXT OF DISTRIBUTIVE SHOCK (REASON FOR ADMISSION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
STUDY PRINCIPAL INVESTIGATOR DECIDES TO CHANGE THE VENTILATION MODE ALLOCATED BY RANDOMIZATION	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
HYPOXIC BRAIN INJURY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk
HEMODYNAMIC INSTABILITY	Cardiac disorders	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
SIGNIFICANT HYPOXEMIA	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
SUSPICION OF SEPSIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Ventilator-associated pneumonia (VAP)	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk
ATELECTASIS OF LEFT LUNG	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk
DESOBSTRUCTION FIBROSCOPY	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk
Barotrauma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk
Faulty Spo2 Sensor	Product Issues	Systematic Assessment	EG0000 events0 affected31 at risk EG0011 events1 affected31 at risk
MULTIPLE PERIODS OF VENT DESYNCHRONY	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected31 at risk EG0010 events0 affected31 at risk

Ancestor Terms

ID	Term
D014474	Unconsciousness
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D008173	Lung Diseases, Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D003128	Coma
D012128	Respiratory Distress Syndrome
D029424	Pulmonary Disease, Chronic Obstructive
D009765	Obesity