Postoperative Pulmonary AtelectasisECODIANCT04701541
Perioperative Diaphragmatic Ultrasound as Predictive Index of Atelectasis in Bariatric Surgery
A study testing Diaphragmatic Ultrasound in people with Postoperative Pulmonary Atelectasis and Morbid Obesity, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
In this study the Authors assume that peri-operative changes in DIA are predictive of postoperative atelectasis, thus providing a clinically useful tool to stratify the need for high-intensity monitoring, including admission to intensive care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pulmonary Atelectasis, Morbid Obesity
- What is being tested?
- Diaphragmatic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 May 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morbid obesity undergoing bariatric surgery (BMI >30 Kg/m2)
Who cannot join
- Heart Failure
- Neuromuscular Diseases
- Previous Thoracic Surgery,
- American Society of Anesthesiology physical (ASA) status >III.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Hospital Policlinico Umberto I of Rome
Roma, 00155
About this study
Official title: Is the Perioperative Change in Ultrasound-based Diaphragmatic Inspiratory Amplitude Predictive of Postoperative Atelectasis: A Prospective Observational Study in Obese Patients Undergoing Bariatric Surgery
In this study the Authors assume that peri-operative changes in DIA are predictive of postoperative atelectasis, thus providing a clinically useful tool to stratify the need for high-intensity monitoring, including admission to intensive care. Aim of this prospective observational study, in obese patients undergoing sleeve gastrectomy, is to evaluate the relationship between pre to postoperative changes in US-DIA and PaO2/FiO2.
Read the detailed description
Obese patients undergoing bariatric surgery, are at high risk for postoperative respiratory complications but predictive variables, risk factors and criteria for postoperative ICU admission are debated. In these patients, postoperative respiratory complications are related to various pathophysiological mechanisms that include: decreased lung volumes, respiratory muscle dysfunction and atelectasis. Very recently it has also been demonstrated a possible role of molecules that would mediate the fibro-adipogenic remodeling of the diaphragm in the obese, thus increasing the respiratory disability.
Pulmonary atelectasis appears within minutes after anesthesia induction, complicate 85-90% of the cases -involving up to 15% of the lungs and inducing a 5 to 10% of cardiac output intra pulmonary shunting- and determine an increased incidence of postoperative morbidity (with higher incidence of pneumonia). Furthermore, in the perioperative period, obese patients are more likely to develop atelectasis that resolves more slowly than in non-obese patients. Surgical handling of sub diaphragmatic region, as during sleeve gastrectomy, can impair diaphragmatic excursions thus contributing to postoperative pulmonary dysfunction. The same upper abdominal surgery represents a risk factor for the development of pulmonary complications in the perioperative period and alteration of the respiratory function indices.
Ultrasounds (US) imaging is a real-time, bedside, non-invasive technique that allows the quantitative evaluation of amplitude, force and velocity of diaphragmatic movement, including: diaphragmatic inspiratory amplitude (DIA) and diaphragmatic thickening. The US-DIA is a qualified quantitative approach to assess diaphragmatic function and has been reported to linearly correlate with vital capacity. Recent studies have also correlated diaphragmatic dysfunction, which reduces the ability to generate total current volume, with the onset of atelectasis, but in a very specialized and dedicated area such as thoracic surgery. The originality of the study lies in the fact that the investigators have translated this method of evaluation of diaphragmatic function, as a predictive index of pulmonary complications in postoperative surgery, into a highly selected and clinically demanding type of patient, such as the patient suffering from pathological obesity.
Several guidelines have been created at European level for the perioperative management of the obese patient. One of the most recent is the one created by the Italian Society of Anaesthesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), which commissioned an "Obesity Task Force" of the Airway Management Study Group to coordinate a multidisciplinary multi-professional consensus project to identify bundles of Good Clinical Practices (GCPs), useful to define the risks in adult obese patients in hospital.
In obese patients undergoing sleeve gastrectomy there are no conclusive criteria for discharge and indications to postoperative ICU admission, as recently defined for patients with OSAS, the investigators hypothesize that perioperative change in US-DIA predicts postoperative atelectasis, thus providing a clinically useful tool to stratify the need for higher intensity monitoring including ICU admission.
- Being tested
- Diaphragmatic Ultrasound
- Keywords
- Atelectasis, Diaphragmatic Inspiratory Amplitude, Obesity
- Medical subject headings
- Pulmonary Atelectasis, Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic UltrasoundDevice
Also called Ultrasound-based Diaphragmatic Inspiratory Amplitude, ECO-DIA
Diaphragmatic ultrasound is non-invasive, portable, quick to perform, with a linear relationship between diaphragmatic movement and inspired volume. In eligible patients, a preoperative baseline ultrasound evaluation of the diaphragm and lungs is accomplished. Evaluation will be performed by a single operator, blinded to the arterial blood gas analysis values. In a semi recumbent position, patients will be asked to rest and breath quietly. An anterior approach will be carried out applying freehand transducer on abdomen at the right midclavicular line immediately below the costal margin with firm pressure, steering in cranial direction. A B-mode transverse scanning will be performed looking across the liver with gallbladder in the middle. Measurements will be recorded by the M-mode frozen images. The M-mode modality will be used to study DIA. The best sinusoidal curve will be considered for measurements.
| Study group | Role | What they receive |
|---|---|---|
| Obese Patients undergoing Bariatric Surgery | Other | Obesity is a progressively growing morbid condition in the world, and given the direct relationship between body mass index (BMI) and costs, this has a major impact on economic and health policy. Obese patients undergoing bariatric surgery are at high risk for postoperative respiratory complications. In these patients, postoperative respiratory complications are related to various pathophysiological mechanisms that include: decreased lung volumes, respiratory muscle dysfunction and atelectasis. Demographic (age, gender, BMI) and clinical features of the population included: ASA, comorbidity and pre and postoperative respiratory function [PaO2/FiO2, haemogasanalysis (EGA)]. Ultrasound evaluation of DIA was performed.
T0: preoperative within 24h before surgery: DIA, haemogasanalysis; T1: Post operation: 60 min after extubation: Aldrete Score, DIA, EGA; T2: Post operation: 240 min after extubation: Aldrete, EGA. Receives: Device: Diaphragmatic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between diaphragmatic excursion and post-operative atelectasis
to detect the relationship between perioperative changes in DIA, (unit of measurement "millimeters") finally expressed as percentage differences at the baseline, during forced breath and occurrence and severity of postoperative atelectasis (evaluated through PaO2/FiO2 R) at 240 min after extubation (T2), view with haemogasanalytic measurement.
Measured: 240 minutes
Secondary outcomes (5)
amount of neuromuscular blockers
concentration of myorelaxants, expressed in milligrams, used during surgery. Measurement tool is the TOF Ratio [TOF Ratio, is the ratio of the amplitude of the fourth muscle response to the amplitude of the first]. Monitoring guide acceleromyographic train-of-four stimulus to the adductor pollicis.
Measured: During surgery
difference in pre and postoperative DIA during calm breathing
Quantification of the difference in diaphragmatic excursion, DIA (unit of measurement "millimeters") finally expressed as percentage differences at the baseline, during calm breathing between the pre-operative T0 time and the T1 time at 1 hour after the end of the operation.
Measured: During surgery + 1 hour post-surgery
incidence rate of pneumonia on the second postoperative day
The detection of pneumonia was carried out with CURB-65, a simple predictive clinical score based on mental confusion, azotemia (mg/dL), respiratory rate (n breaths/min), blood pressure (mmHg) and age (years). In addition, a chest X-ray was performed to highlight the presence of infiltrations.
Measured: 2 days
hospitalization duration
average length of hospital stay in the post-operative period, in the general surgery department.
Measured: 4 days
need for hospitalization in postoperative ICU
% of the patients need recovery in intensive care due to the onset of a complication during the post-operative course.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Alessandri, University of Roma La Sapienza
- Investigators
- Francesco Alessandri, Principal investigator, Emergency and Acceptance Depart., Anaesth. and Critical Areas, P. Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701541
- Sponsor's protocol ID
- ECODIABAS
- Acronym
- ECODIA
- Status last verified
- Jan 2021
- First submitted
- 11 May 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose DK, Cohen MM, Wigglesworth DF, DeBoer DP. Critical respiratory events in the postanesthesia care unit. Patient, surgical, and anesthetic factors. Anesthesiology. 1994 Aug;81(2):410-8. doi: 10.1097/00000542-199408000-00020.
PubMed 8053592Chung F, Mezei G, Tong D. Pre-existing medical conditions as predictors of adverse events in day-case surgery. Br J Anaesth. 1999 Aug;83(2):262-70. doi: 10.1093/bja/83.2.262.
PubMed 10618941Members of the Working Party; Nightingale CE, Margarson MP, Shearer E, Redman JW, Lucas DN, Cousins JM, Fox WT, Kennedy NJ, Venn PJ, Skues M, Gabbott D, Misra U, Pandit JJ, Popat MT, Griffiths R; Association of Anaesthetists of Great Britain; Ireland Society for Obesity and Bariatric Anaesthesia. Peri-operative management of the obese surgical patient 2015: Association of Anaesthetists of Great Britain and Ireland Society for Obesity and Bariatric Anaesthesia. Anaesthesia. 2015 Jul;70(7):859-76. doi: 10.1111/anae.13101. Epub 2015 May 7.
PubMed 25950621Buras ED, Converso-Baran K, Davis CS, Akama T, Hikage F, Michele DE, Brooks SV, Chun TH. Fibro-Adipogenic Remodeling of the Diaphragm in Obesity-Associated Respiratory Dysfunction. Diabetes. 2019 Jan;68(1):45-56. doi: 10.2337/db18-0209. Epub 2018 Oct 25.
PubMed 30361289Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
PubMed 15791115Asteriou C, Lazopoulos A, Rallis T, Gogakos AS, Paliouras D, Barbetakis N. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study. J Minim Access Surg. 2016 Jul-Sep;12(3):209-13. doi: 10.4103/0972-9941.183483.
PubMed 27279390Reber A, Engberg G, Sporre B, Kviele L, Rothen HU, Wegenius G, Nylund U, Hedenstierna G. Volumetric analysis of aeration in the lungs during general anaesthesia. Br J Anaesth. 1996 Jun;76(6):760-6. doi: 10.1093/bja/76.6.760.
PubMed 8679345Brismar B, Hedenstierna G, Lundquist H, Strandberg A, Svensson L, Tokics L. Pulmonary densities during anesthesia with muscular relaxation--a proposal of atelectasis. Anesthesiology. 1985 Apr;62(4):422-8. doi: 10.1097/00000542-198504000-00009.
PubMed 3885791Gunnarsson L, Tokics L, Gustavsson H, Hedenstierna G. Influence of age on atelectasis formation and gas exchange impairment during general anaesthesia. Br J Anaesth. 1991 Apr;66(4):423-32. doi: 10.1093/bja/66.4.423.
PubMed 2025468Kelkar KV. Post-operative pulmonary complications after non-cardiothoracic surgery. Indian J Anaesth. 2015 Sep;59(9):599-605. doi: 10.4103/0019-5049.165857.
PubMed 26556919Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
PubMed 12456460Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. doi: 10.1164/arrd.1983.128.5.899.
PubMed 6638679Dureuil B, Desmonts JM, Mankikian B, Prokocimer P. Effects of aminophylline on diaphragmatic dysfunction after upper abdominal surgery. Anesthesiology. 1985 Mar;62(3):242-6. doi: 10.1097/00000542-198503000-00006.
PubMed 3977111Manikian B, Cantineau JP, Bertrand M, Kieffer E, Sartene R, Viars P. Improvement of diaphragmatic function by a thoracic extradural block after upper abdominal surgery. Anesthesiology. 1988 Mar;68(3):379-86. doi: 10.1097/00000542-198803000-00010.
PubMed 3344992Nguyen NT, Lee SL, Goldman C, Fleming N, Arango A, McFall R, Wolfe BM. Comparison of pulmonary function and postoperative pain after laparoscopic versus open gastric bypass: a randomized trial. J Am Coll Surg. 2001 Apr;192(4):469-76; discussion 476-7. doi: 10.1016/s1072-7515(01)00822-5.
PubMed 11294404
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Perioperative Change in Ultrasound-based Diaphragmatic Inspiratory Amplitude Predictive of Postoperative Atelectasis: A Prospective Observational Study in Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04701541
- Acronym / sponsor ID
- ECODIA / ECODIABAS
- Keywords
- Atelectasis, Diaphragmatic Inspiratory Amplitude, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 8 Jan 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.
In this study the Authors assume that peri-operative changes in DIA are predictive of postoperative atelectasis, thus providing a clinically useful tool to stratify the need for high-intensity monitoring, including admission to intensive care. Aim of this prospective observational study, in obese patients undergoing sleeve gastrectomy, is to evaluate the relationship between pre to postoperative changes in US-DIA and PaO2/FiO2.
Detailed description
Obese patients undergoing bariatric surgery, are at high risk for postoperative respiratory complications but predictive variables, risk factors and criteria for postoperative ICU admission are debated. In these patients, postoperative respiratory complications are related to various pathophysiological mechanisms that include: decreased lung volumes, respiratory muscle dysfunction and atelectasis. Very recently it has also been demonstrated a possible role of molecules that would mediate the fibro-adipogenic remodeling of the diaphragm in the obese, thus increasing the respiratory disability.
Pulmonary atelectasis appears within minutes after anesthesia induction, complicate 85-90% of the cases -involving up to 15% of the lungs and inducing a 5 to 10% of cardiac output intra pulmonary shunting- and determine an increased incidence of postoperative morbidity (with higher incidence of pneumonia). Furthermore, in the perioperative period, obese patients are more likely to develop atelectasis that resolves more slowly than in non-obese patients. Surgical handling of sub diaphragmatic region, as during sleeve gastrectomy, can impair diaphragmatic excursions thus contributing to postoperative pulmonary dysfunction. The same upper abdominal surgery represents a risk factor for the development of pulmonary complications in the perioperative period and alteration of the respiratory function indices.
Ultrasounds (US) imaging is a real-time, bedside, non-invasive technique that allows the quantitative evaluation of amplitude, force and velocity of diaphragmatic movement, including: diaphragmatic inspiratory amplitude (DIA) and diaphragmatic thickening. The US-DIA is a qualified quantitative approach to assess diaphragmatic function and has been reported to linearly correlate with vital capacity. Recent studies have also correlated diaphragmatic dysfunction, which reduces the ability to generate total current volume, with the onset of atelectasis, but in a very specialized and dedicated area such as thoracic surgery. The originality of the study lies in the fact that the investigators have translated this method of evaluation of diaphragmatic function, as a predictive index of pulmonary complications in postoperative surgery, into a highly selected and clinically demanding type of patient, such as the patient suffering from pathological obesity.
Several guidelines have been created at European level for the perioperative management of the obese patient. One of the most recent is the one created by the Italian Society of Anaesthesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), which commissioned an "Obesity Task Force" of the Airway Management Study Group to coordinate a multidisciplinary multi-professional consensus project to identify bundles of Good Clinical Practices (GCPs), useful to define the risks in adult obese patients in hospital.
In obese patients undergoing sleeve gastrectomy there are no conclusive criteria for discharge and indications to postoperative ICU admission, as recently defined for patients with OSAS, the investigators hypothesize that perioperative change in US-DIA predicts postoperative atelectasis, thus providing a clinically useful tool to stratify the need for higher intensity monitoring including ICU admission.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Patients undergoing Bariatric Surgery | Other | Device: Diaphragmatic UltrasoundObesity is a progressively growing morbid condition in the world, and given the direct relationship between body mass index (BMI) and costs, this has a major impact on economic and health policy. Obese patients undergoing bariatric surgery are at high risk for postoperative respiratory complications. In these patients, postoperative respiratory complications are related to various pathophysiological mechanisms that include: decreased lung volumes, respiratory muscle dysfunction and atelectasis. Demographic (age, gender, BMI) and clinical features of the population included: ASA, comorbidity and pre and postoperative respiratory function [PaO2/FiO2, haemogasanalysis (EGA)]. Ultrasound evaluation of DIA was performed. T0: preoperative within 24h before surgery: DIA, haemogasanalysis; T1: Post operation: 60 min after extubation: Aldrete Score, DIA, EGA; T2: Post operation: 240 min after extubation: Aldrete, EGA. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- morbid obesity undergoing bariatric surgery (BMI >30 Kg/m2)
Key exclusion criteria (4 listed)
- Heart Failure
- Neuromuscular Diseases
- Previous Thoracic Surgery,
- American Society of Anesthesiology physical (ASA) status >III.
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 |
|---|---|---|
| Diaphragmatic UltrasoundAlso: Ultrasound-based Diaphragmatic Inspiratory Amplitude, ECO-DIADiaphragmatic ultrasound is non-invasive, portable, quick to perform, with a linear relationship between diaphragmatic movement and inspired volume. In eligible patients, a preoperative baseline ultrasound evaluation of the diaphragm and lungs is accomplished. Evaluation will be performed by a single operator, blinded to the arterial blood gas analysis values. In a semi recumbent position, patients will be asked to rest and breath quietly. An anterior approach will be carried out applying freehand transducer on abdomen at the right midclavicular line immediately below the costal margin with firm pressure, steering in cranial direction. A B-mode transverse scanning will be performed looking across the liver with gallbladder in the middle. Measurements will be recorded by the M-mode frozen images. The M-mode modality will be used to study DIA. The best sinusoidal curve will be considered for measurements. | Device | Obese Patients undergoing Bariatric Surgery |
Primary outcome
Correlation between diaphragmatic excursion and post-operative atelectasis
Time frame: 240 minutes
to detect the relationship between perioperative changes in DIA, (unit of measurement "millimeters") finally expressed as percentage differences at the baseline, during forced breath and occurrence and severity of postoperative atelectasis (evaluated through PaO2/FiO2 R) at 240 min after extubation (T2), view with haemogasanalytic measurement.
5 secondary outcomes
amount of neuromuscular blockers
Time frame: During surgery
difference in pre and postoperative DIA during calm breathing
Time frame: During surgery + 1 hour post-surgery
incidence rate of pneumonia on the second postoperative day
Time frame: 2 days
hospitalization duration
Time frame: 4 days
need for hospitalization in postoperative ICU
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 8053592Rose DK, Cohen MM, Wigglesworth DF, DeBoer DP. Critical respiratory events in the postanesthesia care unit. Patient, surgical, and anesthetic factors. Anesthesiology. 1994 Aug;81(2):410-8. doi: 10.1097/00000542-199408000-00020.
- Background: PubMed 10618941Chung F, Mezei G, Tong D. Pre-existing medical conditions as predictors of adverse events in day-case surgery. Br J Anaesth. 1999 Aug;83(2):262-70. doi: 10.1093/bja/83.2.262.
- Background: PubMed 25950621Members of the Working Party; Nightingale CE, Margarson MP, Shearer E, Redman JW, Lucas DN, Cousins JM, Fox WT, Kennedy NJ, Venn PJ, Skues M, Gabbott D, Misra U, Pandit JJ, Popat MT, Griffiths R; Association of Anaesthetists of Great Britain; Ireland Society for Obesity and Bariatric Anaesthesia. Peri-operative management of the obese surgical patient 2015: Association of Anaesthetists of Great Britain and Ireland Society for Obesity and Bariatric Anaesthesia. Anaesthesia. 2015 Jul;70(7):859-76. doi: 10.1111/anae.13101. Epub 2015 May 7.
- Background: PubMed 30361289Buras ED, Converso-Baran K, Davis CS, Akama T, Hikage F, Michele DE, Brooks SV, Chun TH. Fibro-Adipogenic Remodeling of the Diaphragm in Obesity-Associated Respiratory Dysfunction. Diabetes. 2019 Jan;68(1):45-56. doi: 10.2337/db18-0209. Epub 2018 Oct 25.
- Background: PubMed 15791115Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
- Background: PubMed 27279390Asteriou C, Lazopoulos A, Rallis T, Gogakos AS, Paliouras D, Barbetakis N. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study. J Minim Access Surg. 2016 Jul-Sep;12(3):209-13. doi: 10.4103/0972-9941.183483.
- Background: PubMed 8679345Reber A, Engberg G, Sporre B, Kviele L, Rothen HU, Wegenius G, Nylund U, Hedenstierna G. Volumetric analysis of aeration in the lungs during general anaesthesia. Br J Anaesth. 1996 Jun;76(6):760-6. doi: 10.1093/bja/76.6.760.
- Background: PubMed 3885791Brismar B, Hedenstierna G, Lundquist H, Strandberg A, Svensson L, Tokics L. Pulmonary densities during anesthesia with muscular relaxation--a proposal of atelectasis. Anesthesiology. 1985 Apr;62(4):422-8. doi: 10.1097/00000542-198504000-00009.
- Background: PubMed 2025468Gunnarsson L, Tokics L, Gustavsson H, Hedenstierna G. Influence of age on atelectasis formation and gas exchange impairment during general anaesthesia. Br J Anaesth. 1991 Apr;66(4):423-32. doi: 10.1093/bja/66.4.423.
- Background: PubMed 26556919Kelkar KV. Post-operative pulmonary complications after non-cardiothoracic surgery. Indian J Anaesth. 2015 Sep;59(9):599-605. doi: 10.4103/0019-5049.165857.
- Background: PubMed 12456460Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
- Background: PubMed 6638679Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. doi: 10.1164/arrd.1983.128.5.899.
- Individual participant dataSharing planned: No
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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.
Francesco Alessandri principal investigator
Emergency and Acceptance Depart., Anaesth. and Critical Areas, P. Umberto I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Ultrasound in people with Postoperative Pulmonary Atelectasis and Morbid Obesity, run by University of Roma La Sapienza at 1 site in Italy.
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 1 inclusion and 4 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 8 Jan 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 Italy. 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?
Contact Francesco Alessandri (0649978024 ext. 0339, francesco.alessandri@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between diaphragmatic excursion and post-operative atelectasis (time frame: 240 minutes). 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 NCT04701541, which also lists 24 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 8 Jan 2021.