Successful WeaningNCT03894436
Ultrasound-Guided Diaphragmatic Thickness Assessment as an Indicator of Successful Extubation in Mechanically Ventilated
An observational study of Successful Weaning and Weaning Failure, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Weaning of mechanically ventilated patient is a daily challenge in Intensive Care units. Several indexes have been employed to assess the patient's ability to recover efficient spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Successful Weaning, Weaning Failure
- What is being tested?
- Ultrasound assessment of diaphragm thickness in B-mode
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2018to 21 Nov 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty patients were recruited during the immediate postoperative period after major elective cancer surgery who needed mechanical ventilation (MV) due to a respiratory cause and met criteria for a spontaneous breathing trial with pressure support ventilation and diaphragm thickness is assessed by using b-mode ultrasound.
Who may be able to join
- Age18-65 years.
- ASA class 1 to 3,
- body mass index (BMI) between 20 and 40 kg/m2
- intubation for ≥ 48 hours
- Types of abdominal cancer surgery included partial gastrectomy, hysterectomy, Splenectomy, hepatectomy, and colectomy.
Who cannot join
- Hemodynamic instability requiring vasopressors.
- Gas exchange impairment requiring positive end-expiratory pressure (PEEP) >10 cmH2O and/or FIO2 > 50% to obtain a PaO2 > 60 mmHg.
- Pressure support (PS) level > 20 cmH2O.
- Body temperature > 38°C or < 35°C.
- Deep sedation state (RASS score < -1).
- History of chronic obstructive pulmonary disease, neuromuscular disease, anatomical malformation of the diaphragm, or use of muscle paralyzing agents, aminoglycosides and corticosteroids.
- Pneumothorax or pneumomediastinum, increase intrabdominal pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Diaphragmatic Thickness Assessment as an Indicator of Successful Extubation in Mechanically Ventilated Cancer Patients
Weaning of mechanically ventilated patient is a daily challenge in Intensive Care units. Several indexes have been employed to assess the patient's ability to recover efficient spontaneous breathing. As the diaphragm is the main respiratory muscle, direct measurement of diaphragmatic function as predictors of extubation success or failure have not been extensively evaluated. Ultrasound can easily access diaphragm thickness (tdi) in its zone of apposition during, tdi can represent the contractile activity of the diaphragm and the efficiency of its function.
Read the detailed description
Each patient will have an orotracheal tube, and will be mechanically ventilated in pressure support ventilation (PSV) mode according to the clinical needs. Local guidelines for sedation of postoperative patients prescribe the use of an intravenous (iv) continuous infusion of propofol, starting at 1.5 mg/kg/h and titrated to obtain a Richmond agitation-sedation scale (RASS) score of 0/-1. Analgesia is provided as a 6- to 8-ml/h continuous epidural infusion of bupivacaine 0.125% + fentanyl 2-mcg/ml solution, aiming at a verbal numerical rating <4 or a behavioral pain scale <7. If epidural analgesia is not feasible, patients receive 0.5 to 1 mg/kg/h continuous iv infusion of morphine + iv acetaminophen 1 g three/four times per day. Patients enrolled when judged to be eligible for a test of weaning from mechanical ventilation, following the local weaning guidelines, that is, adequate cough, absence of excessive tracheobronchial secretion, clinical stability, heart rate (HR) <140/min, systolic blood pressure between 90 and 140 mmHg, arterial partial pressure of oxygen/inspired oxygen fraction (PaO2/FIO2) ≥150 mmHg, respiratory rate <35/min, maximal inspiratory pressure < -20 cmH2O, respiratory rate/tidal volume ratio <105 breaths/(min/l) [19]. Weaning trials consisted of spontaneous breathing(SB) trials on PS mode (reducing PS by 5 cm H2O until a PS level of Δ5/5 was obtained). A successful extubation will be defined as SB for >48 h following extubation. A failed extubation will be defined as reintubation within 48 h. The RSBI (f in breaths/minute (f)/tidal volume in liters (VT)will be calculated simultaneously with ultrasound measurements of tdi and simultaneously with other criteria for weaning.
TECHNIQUE Diaphragm thickness (tdi) was measured using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine). The right hemidiaphragm was imaged at the zone of apposition of the diaphragm and rib cage in the midaxillary line between the 8th and 10th intercostal spaces as previously described.[18] All patients were studied with the head of bed elevated between 20° and 40°. The tdi was measured at end-expiration and end-inspiration. The percent change in tdi between end-expiration and end-inspiration (Δtdi%) was calculated as (tdi end-inspiration-tdi end-expiration/tdi end-expiration) ×100. The Δtdi% for each patient represented the mean of three to five breaths. Images were obtained within the first 5 min of the PS trial and immediate before extubation. Data will be collected: 1. Diaphragmatic thickness. 2. The percent change in tdi between end-expiration and end-inspiration Δtdi%. 3. Arterial blood gases (ABG). 4. Rapid Shallow Breathing Index (RSBI) = Respiratory rate/Tidal volume. 5. Duration of ventilator treatment. 6. Success and failure rate of weaning. 7. Body mass index (BMI).
- Conditions
- Successful Weaning, Weaning Failure
- Being tested
- Ultrasound assessment of diaphragm thickness in B-mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of diaphragm thickness in B-modeCombination product
Also called Rapid shallow breathing index, Arterial blood gases
assess the thickness of diaphragm needed as a tool for prediction of extubation and proper timing of weaning from mechanical ventilation in the ICU which is measured by B mode ultrasound in ventilated cancer patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of diaphragm thickness compared to ABG as standard for weaning
diagnostic accuracy of diaphragm thickness to predict weaning compared to ABG
Measured: 6 months
Sensitivity and specificity of diaphragm delta tdi compared to ABG as standard for weaning
diagnostic accuracy of diaphragm delta tdi to predict weaning compared to ABG
Measured: 6 months
Secondary outcomes (1)
Sensitivity and specificity of RSBI compared to ABG as gold standard for weaning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start30 Jan 2018
- Primary completion25 Aug 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Successful WeaningStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Soliman, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894436
- Sponsor's protocol ID
- IRB00004025
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Diaphragmatic Thickness Assessment as an Indicator of Successful Extubation in Mechanically Ventilated Cancer Patients
- ClinicalTrials.gov ID
- NCT03894436
- Acronym / sponsor ID
- IRB00004025
- Conditions
- Successful Weaning, Weaning Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 28 Mar 2019 (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.
Weaning of mechanically ventilated patient is a daily challenge in Intensive Care units. Several indexes have been employed to assess the patient's ability to recover efficient spontaneous breathing. As the diaphragm is the main respiratory muscle, direct measurement of diaphragmatic function as predictors of extubation success or failure have not been extensively evaluated. Ultrasound can easily access diaphragm thickness (tdi) in its zone of apposition during, tdi can represent the contractile activity of the diaphragm and the efficiency of its function.
Detailed description
Each patient will have an orotracheal tube, and will be mechanically ventilated in pressure support ventilation (PSV) mode according to the clinical needs. Local guidelines for sedation of postoperative patients prescribe the use of an intravenous (iv) continuous infusion of propofol, starting at 1.5 mg/kg/h and titrated to obtain a Richmond agitation-sedation scale (RASS) score of 0/-1. Analgesia is provided as a 6- to 8-ml/h continuous epidural infusion of bupivacaine 0.125% + fentanyl 2-mcg/ml solution, aiming at a verbal numerical rating <4 or a behavioral pain scale <7. If epidural analgesia is not feasible, patients receive 0.5 to 1 mg/kg/h continuous iv infusion of morphine + iv acetaminophen 1 g three/four times per day. Patients enrolled when judged to be eligible for a test of weaning from mechanical ventilation, following the local weaning guidelines, that is, adequate cough, absence of excessive tracheobronchial secretion, clinical stability, heart rate (HR) <140/min, systolic blood pressure between 90 and 140 mmHg, arterial partial pressure of oxygen/inspired oxygen fraction (PaO2/FIO2) ≥150 mmHg, respiratory rate <35/min, maximal inspiratory pressure < -20 cmH2O, respiratory rate/tidal volume ratio <105 breaths/(min/l) [19]. Weaning trials consisted of spontaneous breathing(SB) trials on PS mode (reducing PS by 5 cm H2O until a PS level of Δ5/5 was obtained). A successful extubation will be defined as SB for >48 h following extubation. A failed extubation will be defined as reintubation within 48 h. The RSBI (f in breaths/minute (f)/tidal volume in liters (VT)will be calculated simultaneously with ultrasound measurements of tdi and simultaneously with other criteria for weaning.
TECHNIQUE Diaphragm thickness (tdi) was measured using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine). The right hemidiaphragm was imaged at the zone of apposition of the diaphragm and rib cage in the midaxillary line between the 8th and 10th intercostal spaces as previously described.[18] All patients were studied with the head of bed elevated between 20° and 40°. The tdi was measured at end-expiration and end-inspiration. The percent change in tdi between end-expiration and end-inspiration (Δtdi%) was calculated as (tdi end-inspiration-tdi end-expiration/tdi end-expiration) ×100. The Δtdi% for each patient represented the mean of three to five breaths. Images were obtained within the first 5 min of the PS trial and immediate before extubation. Data will be collected: 1. Diaphragmatic thickness. 2. The percent change in tdi between end-expiration and end-inspiration Δtdi%. 3. Arterial blood gases (ABG). 4. Rapid Shallow Breathing Index (RSBI) = Respiratory rate/Tidal volume. 5. Duration of ventilator treatment. 6. Success and failure rate of weaning. 7. Body mass index (BMI).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty patients were recruited during the immediate postoperative period after major elective cancer surgery who needed mechanical ventilation (MV) due to a respiratory cause and met criteria for a spontaneous breathing trial with pressure support ventilation and diaphragm thickness is assessed by using b-mode ultrasound.
Key inclusion criteria (5 listed)
- Age18-65 years.
- ASA class 1 to 3,
- body mass index (BMI) between 20 and 40 kg/m2
- intubation for ≥ 48 hours
- Types of abdominal cancer surgery included partial gastrectomy, hysterectomy, Splenectomy, hepatectomy, and colectomy.
Key exclusion criteria (7 listed)
- Hemodynamic instability requiring vasopressors.
- Gas exchange impairment requiring positive end-expiratory pressure (PEEP) >10 cmH2O and/or FIO2 > 50% to obtain a PaO2 > 60 mmHg.
- Pressure support (PS) level > 20 cmH2O.
- Body temperature > 38°C or < 35°C.
- Deep sedation state (RASS score < -1).
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 |
|---|---|---|
| Ultrasound assessment of diaphragm thickness in B-modeAlso: Rapid shallow breathing index, Arterial blood gasesassess the thickness of diaphragm needed as a tool for prediction of extubation and proper timing of weaning from mechanical ventilation in the ICU which is measured by B mode ultrasound in ventilated cancer patients | Combination product | – |
Primary outcome
Sensitivity and specificity of diaphragm thickness compared to ABG as standard for weaning
Time frame: 6 months
diagnostic accuracy of diaphragm thickness to predict weaning compared to ABG
Sensitivity and specificity of diaphragm delta tdi compared to ABG as standard for weaning
Time frame: 6 months
diagnostic accuracy of diaphragm delta tdi to predict weaning compared to ABG
1 secondary outcome
Sensitivity and specificity of RSBI compared to ABG as gold standard for weaning
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Successful Weaning and Weaning Failure, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of diaphragm thickness compared to ABG as standard for weaning (time frame: 6 months). The study lists 2 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 2019.