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NCT Number: NCT05865977

dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

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Key information

Conditions

Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
  • All the indications for extubation are met：cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: MAP < 8cmH2O, RR < 30 times/min, FiO2 < 30%; Arterial blood gas: pH > 7.25, (PaCO2< 60mmHg, BE < 8mmol/L, oxygen saturation > 90%
  • a successful SBT
  • parents or legal guardians sign informed consent to attend this study

Exclusion criteria

  • accidental extubation
  • chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
  • complex congenital heart disease
  • congenital metabolic diseases, neuromuscular diseases
  • severe brain injury
  • surgical mechanical ventilation
  • give up before extubation;
  • pneumothorax or pleural effusion
  • no consent is signed

Treatment and study plan

diaphragmatic tissue Doppler imaging，dTDI

Device

dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.

Primary outcomes

  1. Change in diaphragmatic displacement velocity

    Time frame: an average of 20 minutes

    Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.

Secondary outcomes

  1. Diaphragmatic acceleration and deceleration

    Time frame: an average of 20 minutes

    Diaphragmatic acceleration and deceleration evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.

  2. Gas exchange - arterial carbon dioxide tension

    Time frame: through each trial completion, an average of 20 minutes

    Arterial blood gases sample

  3. Gas exchange - pH

    Time frame: an average of 20 minutes

    Arterial blood gases sample

  4. Gas exchange - arterial oxygen tension

    Time frame: an average of 20 min

    Arterial blood gases sample

  5. Silverman Andersen Respiratory Severity Score (SA-RSS)

    Time frame: an average of 20 min

    SA-RSS to assess work of breathing after extubation.

  6. Number of patients who experienced weaning failure

    Time frame: 48 hours

    the need for non invasive ventilation or re-intubation due to any cause

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Wang Jianhui

Other

Registry information

Official study title

Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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