AssessmentNCT04991727
Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound
An observational study of Assessment, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Peri - operative ultrasonography was used to evaluate the effects of protective lung ventilation on the postoperative lungs of obese patients.The purpose of this study was to apply ultrasound lung ventilation area score to the monitoring of pulmonary complications in patients with postoperative obesity.To verify the… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment
- What is being tested?
- recruitment maneuvers
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2021to 23 Dec 2023
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective surgery, non-cardiac surgery, in the Heart and Brain Hospital of Ningxia Medical University from June, 2021 to October, 2023
Who may be able to join
- enrollment of patients aged 18 years or above；
- Eligible adult patients had an American Society of Anesthesiologists (ASA) physical status classification of I to IV
- undergoing elective or expedited nonurgent, noncardiac surgery with general anesthesia
Who cannot join
- patient refusal;
- morbid obesity (BMI >40 kg/ m²);
- American Society of Anesthesiologists (ASA) physical status categories IV-V;
- previous intrathoracic procedure;
- severechronic obstructive pulmonary disease (forced expiratory volume in 1 s <30% of the predicted value;
- a contraindication to radial artery cannulation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Ma Hanxiang, +86-13519591508, mahanxiang@hotmail.com
About this study
Official title: Pulmonary Ultrasound to Evaluate Protective Lung Ventilation in Obese Patients With Postoperative Pulmonary Complications Impact
Peri - operative ultrasonography was used to evaluate the effects of protective lung ventilation on the postoperative lungs of obese patients.The purpose of this study was to apply ultrasound lung ventilation area score to the monitoring of pulmonary complications in patients with postoperative obesity.To verify the reliability and practicability of perioperative lung ultrasound quantitative scoring.
Read the detailed description
Ultrasound lung ventilation area score was applied to monitor the pulmonary complications of patients after obesity operation to verify the perioperative period.
The reliability and practicability of quantitative lung ultrasound score to clarify the effect of protective lung ventilation under perioperative pulmonary ultrasound monitoring on obesity patients.To guide the management of mechanical ventilation under general anesthesia and the prevention and treatment of postoperative pulmonary complications
- Conditions
- Assessment
- Being tested
- recruitment maneuvers
- Keywords
- lung ultrasound, Protective pulmonary ventilation, Postoperative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuversBehavioural
Immediately after endotracheal intubation is completed
First RM (pulmonary retraction), maintain pressure at 40cmH2O for 30s, and then
Mechanical ventilation was maintained with 7cmH2O PEEP, and the RMS was repeated every 30 minutes until the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| PEEP | The patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway.Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed.Pulmonary ultrasound was performed. The PEEPgroup was given the first RM (pulmonary retraction) with pressure maintained at 40cmH2O for 30s, followed by a 7cmH2O PEEP to maintain mechanical ventilation, and the RMS was repeated every 30 minutes until the end of surgery Receives: Behavioral: recruitment maneuvers | |
| ZEEP | The patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway. Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed
On pulmonary ultrasound, patients in the ZEEP group maintained normal mechanical ventilation throughout the operation without PEEP or RMS Receives: Behavioral: recruitment maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound scoring
Four signs were used in lung ultrasound scoring
Lung ultrasound score: N (0): pleural line and A line, less than 3 B lines; B1 (1 mark): More than 3
B line; B2 (2 points): Fuse line B; C (3 points): Signs of lung consolidation. The higher the score is, the worse the pulmonary ventilation status is.
When scoring, the sign with the greatest severity is taken as the score value of the examination area. There are 12 examination areas in both lungs, so we have a LUS
The score is between 0 and 36
Measured: in the morning of the first day
Secondary outcomes (2)
Results of arterial blood gas analysis
PCO2
Measured: entering the operating room, in the morning of the first day ,the second day , the third day after surgery
Mechanical ventilation parameter
peak inspiratory pressure
Measured: entering the operating room, in the morning of the first day ,the second day , the third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start21 Aug 2021 (estimated)
- Primary completion23 Oct 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AssessmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991727
- Sponsor's protocol ID
- KYLL-2021-277
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wanguemert Perez AL. Clinical applications of pulmonary ultrasound. Med Clin (Barc). 2020 Apr 10;154(7):260-268. doi: 10.1016/j.medcli.2019.11.001. Epub 2020 Jan 8. English, Spanish.
PubMed 31926654Costamagna A, Pivetta E, Goffi A, Steinberg I, Arina P, Mazzeo AT, Del Sorbo L, Veglia S, Davini O, Brazzi L, Ranieri VM, Fanelli V. Clinical performance of lung ultrasound in predicting ARDS morphology. Ann Intensive Care. 2021 Mar 29;11(1):51. doi: 10.1186/s13613-021-00837-1.
PubMed 33779834
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Ultrasound to Evaluate Protective Lung Ventilation in Obese Patients With Postoperative Pulmonary Complications Impact
- ClinicalTrials.gov ID
- NCT04991727
- Acronym / sponsor ID
- KYLL-2021-277
- Conditions
- Assessment
- Keywords
- lung ultrasound, Protective pulmonary ventilation, Postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2021 (estimated)
- Primary completion
- 23 Oct 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 5 Aug 2021 (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.
Peri - operative ultrasonography was used to evaluate the effects of protective lung ventilation on the postoperative lungs of obese patients.The purpose of this study was to apply ultrasound lung ventilation area score to the monitoring of pulmonary complications in patients with postoperative obesity.To verify the reliability and practicability of perioperative lung ultrasound quantitative scoring.
Detailed description
Ultrasound lung ventilation area score was applied to monitor the pulmonary complications of patients after obesity operation to verify the perioperative period.
The reliability and practicability of quantitative lung ultrasound score to clarify the effect of protective lung ventilation under perioperative pulmonary ultrasound monitoring on obesity patients.To guide the management of mechanical ventilation under general anesthesia and the prevention and treatment of postoperative pulmonary complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP | – | Behavioral: recruitment maneuversThe patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway.Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed.Pulmonary ultrasound was performed. The PEEPgroup was given the first RM (pulmonary retraction) with pressure maintained at 40cmH2O for 30s, followed by a 7cmH2O PEEP to maintain mechanical ventilation, and the RMS was repeated every 30 minutes until the end of surgery |
| ZEEP | – | Behavioral: recruitment maneuversThe patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway. Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed On pulmonary ultrasound, patients in the ZEEP group maintained normal mechanical ventilation throughout the operation without PEEP or RMS |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery, non-cardiac surgery, in the Heart and Brain Hospital of Ningxia Medical University from June, 2021 to October, 2023
Key inclusion criteria (3 listed)
- enrollment of patients aged 18 years or above；
- Eligible adult patients had an American Society of Anesthesiologists (ASA) physical status classification of I to IV
- undergoing elective or expedited nonurgent, noncardiac surgery with general anesthesia
Key exclusion criteria (6 listed)
- patient refusal;
- morbid obesity (BMI >40 kg/ m²);
- American Society of Anesthesiologists (ASA) physical status categories IV-V;
- previous intrathoracic procedure;
- severechronic obstructive pulmonary disease (forced expiratory volume in 1 s <30% of the predicted value;
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 |
|---|---|---|
| recruitment maneuversImmediately after endotracheal intubation is completed First RM (pulmonary retraction), maintain pressure at 40cmH2O for 30s, and then Mechanical ventilation was maintained with 7cmH2O PEEP, and the RMS was repeated every 30 minutes until the end of surgery | Behavioural | PEEP, ZEEP |
Primary outcome
Lung ultrasound scoring
Time frame: in the morning of the first day
Four signs were used in lung ultrasound scoring Lung ultrasound score: N (0): pleural line and A line, less than 3 B lines; B1 (1 mark): More than 3 B line; B2 (2 points): Fuse line B; C (3 points): Signs of lung consolidation. The higher the score is, the worse the pulmonary ventilation status is. When scoring, the sign with the greatest severity is taken as the score value of the examination area. There are 12 examination areas in both lungs, so we have a LUS The score is between 0 and 36
2 secondary outcomes
Results of arterial blood gas analysis
Time frame: entering the operating room, in the morning of the first day ,the second day , the third day after surgery
Mechanical ventilation parameter
Time frame: entering the operating room, in the morning of the first day ,the second day , the third day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 31926654Wanguemert Perez AL. Clinical applications of pulmonary ultrasound. Med Clin (Barc). 2020 Apr 10;154(7):260-268. doi: 10.1016/j.medcli.2019.11.001. Epub 2020 Jan 8. English, Spanish.
- Background: PubMed 33779834Costamagna A, Pivetta E, Goffi A, Steinberg I, Arina P, Mazzeo AT, Del Sorbo L, Veglia S, Davini O, Brazzi L, Ranieri VM, Fanelli V. Clinical performance of lung ultrasound in predicting ARDS morphology. Ann Intensive Care. 2021 Mar 29;11(1):51. doi: 10.1186/s13613-021-00837-1.
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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.
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 Assessment, run by General Hospital of Ningxia Medical University at 1 site in China.
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 3 inclusion and 6 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 5 Aug 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound scoring (time frame: in the morning of the first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991727, which also lists 2 linked publications.
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 5 Aug 2021.