Hypoxic Respiratory FailureNCT06336265
Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy
An observational study of Hypoxic Respiratory Failure, run by Xingui Dai.
Trial summary
Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoxic Respiratory Failure
- What is being tested?
- Diaphragm ultrasound
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild to moderate hypoxic respiratory failure who are over 18 years old and less than 75 years old and who do not have serious cardiopulmonary disease, malnutrition, or respiratory obstruction and require high-flow nasal cannula oxygen therapy
Who may be able to join
- Age ≥18 years old, less than 75 years old,BMI≥18.5kg/m2
- Mild to moderate type I respiratory failure (100mmHg< PaO2/FiO2≤300mmHg)
- Mild ventilation dysfunction (pH≥7.3)
- Mild respiratory distress (respiratory rate > 24 times/min)
- High-flow nasal cannula oxygen therapy is required
- The patient and immediate family members agree and sign a written informed consent.
Who cannot join
- Patients with severe type II respiratory failure, severe asthma and massive hemoptysis
- Moderate to severe consciousness disorder, GCS score ≤12 points
- Cardiogenic pulmonary edema and cardiogenic dyspnea caused by heart failure, heart valvular disease, myocarditis, etc
- Hemodynamic instability, SBP< 90mmHg, or MAP<65mmHg
- BMI < 18.5kg/m2
- Nasal bleeding, nasal space occupying lesions, etc., can not be high-flow nasal cannula oxygen therapy through the nose or nasal obstruction
Show all 9Show fewer
- Patients with severe hypoxemia, severe ARDS and other conditions requiring immediate tracheal intubation
- The patient or family member refuses to participate or does not agree to sign the written informed consent
- The patient has participated in other research projects with interventions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High Flow Oxygen Therapy in Mild and Moderate Acute Hypoxic Respiratory Failure
Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis.
- Conditions
- Hypoxic Respiratory Failure
- Being tested
- Diaphragm ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm ultrasoundDiagnostic test
Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness and thickening fraction of Diaphragm
Diaphragm thickness and thickening fraction (TFdi) were measured using a high-frequency linear array probe at the midaxillary line. TFdi = (diaphragm thickness at the end of inspirations - diaphragm thickness at the end of expirations)/diaphragm thickness at the end of expirations × 100%
Measured: 0-12 hours
Diaphragmatic excursion
Diaphragmatic excursion was measured using a low-frequency curved array (" abdomen ") probe located directly below the costal arch on the midline of the clavicle.
Measured: 0-12 hours
Respiratory rate
Respiratory rate of the patient after high-flow nasal oxygen therapy
Measured: 0-12 hours
Incidence of tracheal intubation
After the patient uses high-flow nasal oxygen therapy, the panel determine whether the patient needs to undergo tracheal intubation according to the indicators such as symptoms and signs of the patient.
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingui Dai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingui Dai, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336265
- Sponsor's protocol ID
- Diaphragm ultrasound
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High Flow Oxygen Therapy in Mild and Moderate Acute Hypoxic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06336265
- Acronym / sponsor ID
- Diaphragm ultrasound
- Conditions
- Hypoxic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Xingui DaiUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild to moderate hypoxic respiratory failure who are over 18 years old and less than 75 years old and who do not have serious cardiopulmonary disease, malnutrition, or respiratory obstruction and require high-flow nasal cannula oxygen therapy
Key inclusion criteria (6 listed)
- Age ≥18 years old, less than 75 years old,BMI≥18.5kg/m2
- Mild to moderate type I respiratory failure (100mmHg< PaO2/FiO2≤300mmHg)
- Mild ventilation dysfunction (pH≥7.3)
- Mild respiratory distress (respiratory rate > 24 times/min)
- High-flow nasal cannula oxygen therapy is required
Key exclusion criteria (9 listed)
- Patients with severe type II respiratory failure, severe asthma and massive hemoptysis
- Moderate to severe consciousness disorder, GCS score ≤12 points
- Cardiogenic pulmonary edema and cardiogenic dyspnea caused by heart failure, heart valvular disease, myocarditis, etc
- Hemodynamic instability, SBP< 90mmHg, or MAP<65mmHg
- BMI < 18.5kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm ultrasoundRespiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. | Diagnostic test | – |
Primary outcome
Thickness and thickening fraction of Diaphragm
Time frame: 0-12 hours
Diaphragm thickness and thickening fraction (TFdi) were measured using a high-frequency linear array probe at the midaxillary line. TFdi = (diaphragm thickness at the end of inspirations - diaphragm thickness at the end of expirations)/diaphragm thickness at the end of expirations × 100%
Diaphragmatic excursion
Time frame: 0-12 hours
Diaphragmatic excursion was measured using a low-frequency curved array (" abdomen ") probe located directly below the costal arch on the midline of the clavicle.
Respiratory rate
Time frame: 0-12 hours
Respiratory rate of the patient after high-flow nasal oxygen therapy
Incidence of tracheal intubation
Time frame: 0-12 hours
After the patient uses high-flow nasal oxygen therapy, the panel determine whether the patient needs to undergo tracheal intubation according to the indicators such as symptoms and signs of the patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hypoxic Respiratory Failure
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingPhase 2
Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure
ARDS (Acute Respiratory Distress Syndrome), Acute Hypoxic Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Respiratory Failure, run by Xingui Dai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Yang, Master (15886524007, 17546639@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness and thickening fraction of Diaphragm (time frame: 0-12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.