CClinicalTrials.gg
Not yet recruitingNCT06336265Updated Mar 28, 2024

Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy

An observational study in Hypoxic Respiratory Failure, sponsored by Xingui Dai. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Xingui Dai · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
269
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypoxic Respiratory Failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 269 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Xingui Dai is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  1. Age ≥18 years old, less than 75 years old,BMI≥18.5kg/m2
  2. Mild to moderate type I respiratory failure (100mmHg\< PaO2/FiO2≤300mmHg)
  3. Mild ventilation dysfunction (pH≥7.3)
  4. Mild respiratory distress (respiratory rate > 24 times/min)
  5. High-flow nasal cannula oxygen therapy is required
  6. The patient and immediate family members agree and sign a written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe type II respiratory failure, severe asthma and massive hemoptysis
  2. Moderate to severe consciousness disorder, GCS score ≤12 points
  3. Cardiogenic pulmonary edema and cardiogenic dyspnea caused by heart failure, heart valvular disease, myocarditis, etc
  4. Hemodynamic instability, SBP\< 90mmHg, or MAP\<65mmHg
  5. BMI \< 18.5kg/m2
  6. Nasal bleeding, nasal space occupying lesions, etc., can not be high-flow nasal cannula oxygen therapy through the nose or nasal obstruction
  7. Patients with severe hypoxemia, severe ARDS and other conditions requiring immediate tracheal intubation
  8. The patient or family member refuses to participate or does not agree to sign the written informed consent
  9. The patient has participated in other research projects with interventions
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
269 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDiaphragm ultrasound

    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.

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: 0-12 hours

  2. 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.

    Time frame: 0-12 hours

  3. Respiratory rate

    Respiratory rate of the patient after high-flow nasal oxygen therapy

    Time frame: 0-12 hours

  4. 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.

    Time frame: 0-12 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06336265
Lead sponsor
Xingui Dai
Responsible party
Xingui Dai (Chief Physician, First People's Hospital of Chenzhou) — Sponsor-investigator
First posted
Mar 28, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 28, 2024

Study contacts

Feng Yang, Master
Contact
17546639@qq.com
15886524007

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion