Pneumonia ChildhoodNCT03710759
Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia
A study testing Assistive autogenic Drainage in people with Pneumonia Childhood, run by Riphah International University at 1 site in Pakistan.
Trial summary
Quasi experimental study with duration will be of 6 month, data will be collected from Fauji Foundation Hospital, Rawalpindi. Sample size was calculated from open epi tool (2017) was n=60. Non probability convenient type of sampling technique is used. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pneumonia Childhood
- What is being tested?
- Assistive autogenic Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2018to 10 Jun 2019
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- class III \& IV on pneumonia severity index.
- Both genders are included under study.
- Patients on 2nd \& 3rd generation anti-biotic therapy for pneumonia are included.
Who cannot join
- Children with Musculoskeletal, Neuromuscular and Cardiovascular co-morbidities.
- Children with diagnosed lobular pneumonia are also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia - a Quasi Experimental Study
Quasi experimental study with duration will be of 6 month, data will be collected from Fauji Foundation Hospital, Rawalpindi. Sample size was calculated from open epi tool (2017) was n=60. Non probability convenient type of sampling technique is used. Children suffering from pneumonia between the ages 5-15 years with class III \& IV on pneumonia severity index. Both genders are included under study. Patients on 2nd \& 3rd generation anti-biotic therapy for pneumonia are included in the study. Children with musculoskeletal disorders, neuromuscular disorders, cardiovascular co-morbidities and children with diagnosed lobular pneumonia will be excluded. Self-structured questionnaire will be used which includes the demographics, Pneumonia Severity Index, type of Assistive Breathing devices/ Litre of Oxygen support, Vitals, Atrial blood gases(ABG's), Chest X rays and Pediatric Early Warning Sign-Respiratory system.
Read the detailed description
Pneumonia is the number one infectious killer of children under age 5 globally, according to a World Health Organization (WHO) report year 2015, about 9,35,002 children die of pneumonia every year. In the same report it is stated that Pakistan ranks at third among 15 countries contributing to the global burden of child pneumonia. Pneumonia is basically an infection in one or both lungs. It can be caused by bacteria, viruses, or fungi. Bacterial pneumonia is the most common type in infants however in children Respiratory Syncytial Virus (RSV) is most common cause of Viral Pneumonia. Regarding the pathophysiology of Pneumonia, there is an inflammation in the air sacs of lungs, which are called alveoli, resultantly the alveoli are filled with fluid or pus, making it difficult for the patient to breathe. In order to clear the airways assistive techniques are used besides standard airway management. Autogenic drainage (AD) is an airway clearance technique which utilizes controlled breathing at different lung volumes in order to loosen, mobilize and move secretions in three stages towards the larger central airways.One of the modified form of Autogenic Drainage is Assisted Autogenic Drainage (AAD) which is based upon the principles of Autogenic Drainage and is used in infants and younger patient groups. This technique is performed by placing the hands on the child's chest, the therapist manually increases the expiratory flow in order to achieve the different lung volume breathing.
The chapter 07: vol 1 of book "Physiotherapy Intervention" states that the aim of AAD is to achieve an optimal expiratory flow progressively through all generations of bronchi without causing dynamic airway collapse. In 2007 on " Forced expiratory technique, directed cough and autogenic drainage" and sates that these techniques in combined manner are effective in producing significant results.The direct method of chest percussion was first described by Auenbrugger as reported by the European Respiratory Journal, later it was used globally. The Chochrane Library published a research review on Chest physiotherapy for pneumonia in children in 2012, stating that Autogenic drainage is effective in treating cystic fibrosis (CF). In March 2017 on " The use of assisted autogenic drainage in children with acute and chronic respiratory disease" in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before.In 1998 conducted a study on the topic of "Alternatives to percussion and postural drainage: A review of mucus clearance therapies: AD, positive expiratory pressure (PEP), Flutter valve, Intrapulmonary percussive ventilation and high frequency with Thira vest." Since late 1990's work has continuously been done on chronic respiratory diseases like Cystic Fibrosis in relation with Autogenic Drainage however regarding Assisted Autogenic Drainage in children suffering from Pneumonia, there is not much work done according to my knowledge. A study conducted in March 2017 in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before. This study will be going to add Evidence Based Treatment in the practice of Cardiopulmonary Rehabilitation and could be effective treatment of Pneumonia in Children population through Assisted Autogenic Drainage technique of chest clearance. It will be helpful in treating children suffering from Pneumonia by adding literature using an evidence based Chest Physical therapy treatment.
According to the consort guidelines of the assessment of manuscript the only limitation found in the parent study was that the study title included both infants and young children however only infants were actually recruited in the study. The objective of my current study is to determine the effects of Assisted Autogenic Drainage in children with pneumonia.
- Conditions
- Pneumonia Childhood
- Being tested
- Assistive autogenic Drainage
- Keywords
- Pneumonia, Drainage, Autogenic Drainage
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive autogenic DrainageOther
Assistive autogenic Drainage : All the 3 components of Autogenic drainage was given passively to the patients. By placing the hands on the child's chest, the therapist manually increases the expiratory flow to achieve the different lung volume breathing.
| Study group | Role | What they receive |
|---|---|---|
| Assistive Autogenic Drainage | Experimental | Autogenic drainage (AD) is a breathing technique that uses controlled breathing and least amount of coughing to clear secretions from your chest. It involves you hearing and feeling your secretions as you breathe out and controlling the urge to cough until secretions are high up and easily cleared with little effort. Receives: Other: Assistive autogenic Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Blood Gases
change from baseline Atrial Blood Gases (PH, carbon dioxide partial pressure (PCO2), partial pressure of Oxygen PO2, saturation SPO2)
Measured: Day 07
Secondary outcomes (10)
Pulse rate
change from baseline pulse rate
Measured: Day 1
Pulse rate
change from day 1 pulse rate
Measured: Day 3
Pulse rate
change from day 3 pulse rate
Measured: Day 7
Respiratory
change from baseline Respiratory rate
Measured: Day 1
Respiratory
change from day 1 Respiratory rate
Measured: Day 3
Respiratory
change from day 3 Respiratory rate
Measured: Day 7
Chest Xray
change of chest Xrays From baseline
Measured: Day 7
Pediatric Early Warning System (PEWS)
change of PEWs from baseline
Measured: Day 1
Pediatric Early Warning System (PEWS)
change of PEWs from day 1
Measured: Day 3
Pediatric Early Warning System (PEWS)
change of PEWs from day 3
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018
- Primary completion30 May 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumaiyah Obaid, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710759
- Sponsor's protocol ID
- REC Summyia Siddique
- Status last verified
- Sep 2020
- First submitted
- 13 Oct 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chisti MJ, Tebruegge M, La Vincente S, Graham SM, Duke T. Pneumonia in severely malnourished children in developing countries - mortality risk, aetiology and validity of WHO clinical signs: a systematic review. Trop Med Int Health. 2009 Oct;14(10):1173-89. doi: 10.1111/j.1365-3156.2009.02364.x.
PubMed 19772545Alcon A, Fabregas N, Torres A. Pathophysiology of pneumonia. Clin Chest Med. 2005 Mar;26(1):39-46. doi: 10.1016/j.ccm.2004.10.013.
PubMed 15802164Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999 Dec;14(6):1418-24. doi: 10.1183/09031936.99.14614189.
PubMed 10624775Wallaert E, Perez T, Prevotat A, Reychler G, Wallaert B, Le Rouzic O. The immediate effects of a single autogenic drainage session on ventilatory mechanics in adult subjects with cystic fibrosis. PLoS One. 2018 Mar 29;13(3):e0195154. doi: 10.1371/journal.pone.0195154. eCollection 2018.
PubMed 29596479Corten L, Jelsma J, Human A, Rahim S, Morrow BM. Assisted autogenic drainage in infants and young children hospitalized with uncomplicated pneumonia, a pilot study. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1690. Epub 2017 Jul 19.
PubMed 28722167Abdelbasset W, Elnegamy T. Effect of chest physical therapy on pediatrics hospitalized with pneumonia. International Journal of Health and Rehabilitation Sciences. 2015;4(4):219-26.
Agostini P, Knowles N. Autogenic drainage: the technique, physiological basis and evidence. Physiotherapy. 2007 Jun 1;93(2):157-63.
Chaves GS, Fregonezi GA, Dias FA, Ribeiro CT, Guerra RO, Freitas DA, Parreira VF, Mendonca KM. Chest physiotherapy for pneumonia in children. Cochrane Database Syst Rev. 2013 Sep 20;(9):CD010277. doi: 10.1002/14651858.CD010277.pub2.
PubMed 24057988Akre M, Finkelstein M, Erickson M, Liu M, Vanderbilt L, Billman G. Sensitivity of the pediatric early warning score to identify patient deterioration. Pediatrics. 2010 Apr;125(4):e763-9. doi: 10.1542/peds.2009-0338. Epub 2010 Mar 22.
PubMed 20308222Monaghan A. Detecting and managing deterioration in children. Paediatr Nurs. 2005 Feb;17(1):32-5. doi: 10.7748/paed2005.02.17.1.32.c964. No abstract available.
PubMed 15751446Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
PubMed 21411136Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
PubMed 20927359
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia - a Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT03710759
- Acronym / sponsor ID
- REC Summyia Siddique
- Conditions
- Pneumonia Childhood
- Keywords
- Pneumonia, Drainage, Autogenic Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 18 Oct 2018 (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.
Quasi experimental study with duration will be of 6 month, data will be collected from Fauji Foundation Hospital, Rawalpindi. Sample size was calculated from open epi tool (2017) was n=60. Non probability convenient type of sampling technique is used. Children suffering from pneumonia between the ages 5-15 years with class III \& IV on pneumonia severity index. Both genders are included under study. Patients on 2nd \& 3rd generation anti-biotic therapy for pneumonia are included in the study. Children with musculoskeletal disorders, neuromuscular disorders, cardiovascular co-morbidities and children with diagnosed lobular pneumonia will be excluded. Self-structured questionnaire will be used which includes the demographics, Pneumonia Severity Index, type of Assistive Breathing devices/ Litre of Oxygen support, Vitals, Atrial blood gases(ABG's), Chest X rays and Pediatric Early Warning Sign-Respiratory system.
Detailed description
Pneumonia is the number one infectious killer of children under age 5 globally, according to a World Health Organization (WHO) report year 2015, about 9,35,002 children die of pneumonia every year. In the same report it is stated that Pakistan ranks at third among 15 countries contributing to the global burden of child pneumonia. Pneumonia is basically an infection in one or both lungs. It can be caused by bacteria, viruses, or fungi. Bacterial pneumonia is the most common type in infants however in children Respiratory Syncytial Virus (RSV) is most common cause of Viral Pneumonia. Regarding the pathophysiology of Pneumonia, there is an inflammation in the air sacs of lungs, which are called alveoli, resultantly the alveoli are filled with fluid or pus, making it difficult for the patient to breathe. In order to clear the airways assistive techniques are used besides standard airway management. Autogenic drainage (AD) is an airway clearance technique which utilizes controlled breathing at different lung volumes in order to loosen, mobilize and move secretions in three stages towards the larger central airways.One of the modified form of Autogenic Drainage is Assisted Autogenic Drainage (AAD) which is based upon the principles of Autogenic Drainage and is used in infants and younger patient groups. This technique is performed by placing the hands on the child's chest, the therapist manually increases the expiratory flow in order to achieve the different lung volume breathing.
The chapter 07: vol 1 of book "Physiotherapy Intervention" states that the aim of AAD is to achieve an optimal expiratory flow progressively through all generations of bronchi without causing dynamic airway collapse. In 2007 on " Forced expiratory technique, directed cough and autogenic drainage" and sates that these techniques in combined manner are effective in producing significant results.The direct method of chest percussion was first described by Auenbrugger as reported by the European Respiratory Journal, later it was used globally. The Chochrane Library published a research review on Chest physiotherapy for pneumonia in children in 2012, stating that Autogenic drainage is effective in treating cystic fibrosis (CF). In March 2017 on " The use of assisted autogenic drainage in children with acute and chronic respiratory disease" in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before.In 1998 conducted a study on the topic of "Alternatives to percussion and postural drainage: A review of mucus clearance therapies: AD, positive expiratory pressure (PEP), Flutter valve, Intrapulmonary percussive ventilation and high frequency with Thira vest." Since late 1990's work has continuously been done on chronic respiratory diseases like Cystic Fibrosis in relation with Autogenic Drainage however regarding Assisted Autogenic Drainage in children suffering from Pneumonia, there is not much work done according to my knowledge. A study conducted in March 2017 in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before. This study will be going to add Evidence Based Treatment in the practice of Cardiopulmonary Rehabilitation and could be effective treatment of Pneumonia in Children population through Assisted Autogenic Drainage technique of chest clearance. It will be helpful in treating children suffering from Pneumonia by adding literature using an evidence based Chest Physical therapy treatment.
According to the consort guidelines of the assessment of manuscript the only limitation found in the parent study was that the study title included both infants and young children however only infants were actually recruited in the study. The objective of my current study is to determine the effects of Assisted Autogenic Drainage in children with pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assistive Autogenic Drainage | Experimental | Other: Assistive autogenic DrainageAutogenic drainage (AD) is a breathing technique that uses controlled breathing and least amount of coughing to clear secretions from your chest. It involves you hearing and feeling your secretions as you breathe out and controlling the urge to cough until secretions are high up and easily cleared with little effort. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- class III \& IV on pneumonia severity index.
- Both genders are included under study.
- Patients on 2nd \& 3rd generation anti-biotic therapy for pneumonia are included.
Key exclusion criteria (2 listed)
- Children with Musculoskeletal, Neuromuscular and Cardiovascular co-morbidities.
- Children with diagnosed lobular pneumonia are also excluded.
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 |
|---|---|---|
| Assistive autogenic DrainageAssistive autogenic Drainage : All the 3 components of Autogenic drainage was given passively to the patients. By placing the hands on the child's chest, the therapist manually increases the expiratory flow to achieve the different lung volume breathing. | Other | Assistive Autogenic Drainage |
Primary outcome
Atrial Blood Gases
Time frame: Day 07
change from baseline Atrial Blood Gases (PH, carbon dioxide partial pressure (PCO2), partial pressure of Oxygen PO2, saturation SPO2)
10 secondary outcomes
Pulse rate
Time frame: Day 1
Pulse rate
Time frame: Day 3
Pulse rate
Time frame: Day 7
Respiratory
Time frame: Day 1
Respiratory
Time frame: Day 3
Respiratory
Time frame: Day 7
Chest Xray
Time frame: Day 7
Pediatric Early Warning System (PEWS)
Time frame: Day 1
Pediatric Early Warning System (PEWS)
Time frame: Day 3
Pediatric Early Warning System (PEWS)
Time frame: Day 7
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 18 Sep 2020.
- Background: PubMed 19772545Chisti MJ, Tebruegge M, La Vincente S, Graham SM, Duke T. Pneumonia in severely malnourished children in developing countries - mortality risk, aetiology and validity of WHO clinical signs: a systematic review. Trop Med Int Health. 2009 Oct;14(10):1173-89. doi: 10.1111/j.1365-3156.2009.02364.x.
- Background: PubMed 15802164Alcon A, Fabregas N, Torres A. Pathophysiology of pneumonia. Clin Chest Med. 2005 Mar;26(1):39-46. doi: 10.1016/j.ccm.2004.10.013.
- Background: PubMed 10624775Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999 Dec;14(6):1418-24. doi: 10.1183/09031936.99.14614189.
- Background: PubMed 29596479Wallaert E, Perez T, Prevotat A, Reychler G, Wallaert B, Le Rouzic O. The immediate effects of a single autogenic drainage session on ventilatory mechanics in adult subjects with cystic fibrosis. PLoS One. 2018 Mar 29;13(3):e0195154. doi: 10.1371/journal.pone.0195154. eCollection 2018.
- Background: PubMed 28722167Corten L, Jelsma J, Human A, Rahim S, Morrow BM. Assisted autogenic drainage in infants and young children hospitalized with uncomplicated pneumonia, a pilot study. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1690. Epub 2017 Jul 19.
- BackgroundAbdelbasset W, Elnegamy T. Effect of chest physical therapy on pediatrics hospitalized with pneumonia. International Journal of Health and Rehabilitation Sciences. 2015;4(4):219-26.
- BackgroundAgostini P, Knowles N. Autogenic drainage: the technique, physiological basis and evidence. Physiotherapy. 2007 Jun 1;93(2):157-63.
- Background: PubMed 24057988Chaves GS, Fregonezi GA, Dias FA, Ribeiro CT, Guerra RO, Freitas DA, Parreira VF, Mendonca KM. Chest physiotherapy for pneumonia in children. Cochrane Database Syst Rev. 2013 Sep 20;(9):CD010277. doi: 10.1002/14651858.CD010277.pub2.
- Background: PubMed 20308222Akre M, Finkelstein M, Erickson M, Liu M, Vanderbilt L, Billman G. Sensitivity of the pediatric early warning score to identify patient deterioration. Pediatrics. 2010 Apr;125(4):e763-9. doi: 10.1542/peds.2009-0338. Epub 2010 Mar 22.
- Background: PubMed 15751446Monaghan A. Detecting and managing deterioration in children. Paediatr Nurs. 2005 Feb;17(1):32-5. doi: 10.7748/paed2005.02.17.1.32.c964. No abstract available.
- Background: PubMed 21411136Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
- Background: PubMed 20927359Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
- 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.
Sumaiyah Obaid, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive autogenic Drainage in people with Pneumonia Childhood, run by Riphah International University at 1 site in Pakistan.
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 2 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 18 Sep 2020. 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 Pakistan. 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?
Atrial Blood Gases (time frame: Day 07). 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 NCT03710759, which also lists 12 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 18 Sep 2020.