Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Not Applicable

Not yet recruiting

• Conditions: Hypoxemia
• Interventions: Device: Non-invasive BiPAP ventilation; Device: HFNC

• Registration Number: NCT05784636
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Detailed Description

Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 \> 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

Study Timeline

• Study First Submitted: 2022-09-19
• Status Verified: 2022-11
• Study Start: 2023-03
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

1. . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation);
2. Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg);

Exclusion Criteria

1. Missing primary outcome measures
2. Terminal stage of various chronic diseases;
3. The patient or family members do not agree to NIV or HFNI treatment;
4. Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
5. Ventilation dysfunction (pH<7.30)
6. Contradictory breathing
7. The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
8. Serious diseases, such as organ function damage and sepsis;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFNC treatment group	HFNC	On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.
Non-invasive BiPAP ventilation treatment group	HFNC	Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2\>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge
Non-invasive BiPAP ventilation treatment group	Non-invasive BiPAP ventilation	Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2\>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge
HFNC treatment group	Non-invasive BiPAP ventilation	On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.

Primary Outcome Measures

Name	Time	Method
DBIL	up to 9 days	Direct bilirubin in venous blood
EOS	up to 9 days	The number of Venous blood eosinophils in venous blood
height	At the time of enrollment in the clinical study	m
eGFR	up to 9 days	Estimate glomerular filtration rate in venous blood
Total bilirubin	up to 9 days	Serum total bilirubin in venous blood
SO2	On the 9th day after enrollment (On the 8th day after crossover)	Pulse oxygen saturation
BP	On the 9th day after enrollment (On the 8th day after crossover)	Blood pressure (Includes systolic and diastolic blood pressure)
HR	On the 9th day after enrollment (On the 8th day after crossover)	Heart rate
A-aDO2	On the 9th day after enrollment (On the 8th day after crossover)	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Arterial blood K+ concentration	On the 9th day after enrollment (On the 8th day after crossover)	Arterial blood K+ concentration
RR	On the 9th day after enrollment (On the 8th day after crossover)	Respiratory rate
pH	On the 9th day after enrollment (On the 8th day after crossover)	Degree of pH in arterial blood
GLu	On the 4th day after enrollment (On the third day after crossover)	Arterial blood glucose in arterial blood
TCO2	On the 9th day after enrollment (On the 8th day after crossover)	Total carbon dioxide in arterial blood
age	At the time of enrollment in the clinical study	year
PaO2	On the 9th day after enrollment (On the 8th day after crossover)	Partial arterial oxygen pressure
SaO2	On the 9th day after enrollment (On the 8th day after crossover)	Arterial oxygen saturation
FiO2	On the 9th day after enrollment (On the 8th day after crossover)	Fraction of inspiration O2
Glu	On the 9th day after enrollment (On the 8th day after crossover)	Arterial blood glucose in arterial blood
RI	On the 9th day after enrollment (On the 8th day after crossover)	Respiratory Index
Arterial blood Ca2+ concentration	On the 9th day after enrollment (On the 8th day after crossover)	Arterial blood Ca2+ concentration
Arterial blood Na+ concentration	On the 9th day after enrollment (On the 8th day after crossover)	Arterial blood Na+ concentration
MCV	up to 9 days	Mean Corpuscular Volume in venous blood
RDW	up to 9 days	red blood cell distribution width in venous blood
NT-proBNP	up to 9 days	NT-proBNP in venous blood
ESR	up to 9 days	erythrocytesedimentationrate in venous blood
PT	up to 9 days	prothrombin time in venous blood
PCO2	On the 9th day after enrollment (On the 8th day after crossover)	partial pressure of carbon dioxide in arterial blood
Lac	On the 9th day after enrollment (On the 8th day after crossover)	Lactic acid in arterial blood
BE	On the 9th day after enrollment (On the 8th day after crossover)	Base excess in arterial blood
Arterial blood HCO3- concentration	On the 9th day after enrollment (On the 8th day after crossover)	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
tHbc	On the 9th day after enrollment (On the 8th day after crossover)	Total hemoglobin in arterial blood
Weight	At the time of enrollment in the clinical study	Kg
WBC	up to 9 days	The number of white blood cells in venous blood
LYM	up to 9 days	The number of Venous blood lymphocytes in venous blood
MCH	up to 9 days	Mean Corpuscular Haemoglobin Concentration in venous blood
D-Di	up to 9 days	D-Dimer in venous blood
ALT	up to 9 days	alanine transaminase in venous blood
HCT	up to 9 days	hematocrit in venous blood
gender	At the time of enrollment in the clinical study	Male and female
NEU	up to 9 days	The number of Neutrophil granulocyte in venous blood
BAS	up to 9 days	The number of Venous blood Basophils in venous blood
MON	up to 9 days	The number of Venous blood Monocyte cell in venous blood
RBC	up to 9 days	The number of red blood cells in venous blood
HGB	up to 9 days	The number of haemoglobin in venous blood
PDW	up to 9 days	Platelet distributionwidth in venous blood
CRP	up to 9 days	C-reactive protein in venous blood
TP	up to 9 days	Total serum protein in venous blood
ALB	up to 9 days	Albumin protein in venous blood
GLB	up to 9 days	Globulin globulin in venous blood
APTT	up to 9 days	activated partial thromboplastin time in venous blood
PLT	up to 9 days	platelet in venous blood
AST	up to 9 days	Aspartate Transaminase in venous blood
PA	up to 9 days	Serum prealbumin in venous blood
Cr	up to 9 days	creatinine in venous blood
Cys-C	up to 9 days	Cystatin C in venous blood
MPV	up to 9 days	Mean Platelet Volume in venous blood
plateletcrit	up to 9 days	plateletcrit in venous blood
PCT	up to 9 days	Procalcitonin in venous blood
TT	up to 9 days	Thrombin time in venous blood
BUN	up to 9 days	Urea nitrogen in venous blood
Respiratory support time	during hospitalization, approximately 9 days	Daily respiratory support time after patients were enrolled in the clinical study，h/Day
Tracheal intubation	during hospitalization, approximately 9 days	Yes or No
IBIL	up to 9 days	Indirect bilirubin in venous blood
Diaphragm thickness	up to 9 days	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Relief time for dyspnea	during hospitalization, approximately 9 days	Remission time of dyspnea after intervention
Stay in the ICU	during hospitalization, approximately 9 days	Yes or No
Complications	during hospitalization, approximately 9 days	Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure.
Outcome of disease	during hospitalization, approximately 9 days	Get better, get worse, die
Diaphragm mobility	up to 9 days	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.

Secondary Outcome Measures

Name	Time	Method
Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort	during hospitalization, approximately 9 days	Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.
Patient compliance to the treatment	during hospitalization, approximately 9 days	Patients were managed for compliance with the treatment.Dependent judgment; 1. Complete dependence: patients actively cooperate with medical staff in treatment; 2. Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff.; 3. Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.
Dyspnea rating scale	during hospitalization, approximately 9 days	According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China