Respiratory Failure, ICUNCT05698004
A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
A study testing prone positioning in people with Respiratory Failure, ICU, run by Montaser Gamal Ahmed.
Trial summary
Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, ICU
- What is being tested?
- prone positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.
- Exclusion Criteria: Patients will be excluded from the study if they :
- had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Aliae AR Mohamed Hussein contact
About this study
Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.
Read the detailed description
we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.
- Conditions
- Respiratory Failure, ICU
- Being tested
- prone positioning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positioningOther
The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Group-1: prone positioning + standard treatment | Active comparator | Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required. Receives: Other: prone positioning |
| Group-2: Standard treatment only | No intervention | Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants within intervention arm whom need endotracheal intubation.
Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR> 35/min., PaO2/FiO2<200 mmHg, and respiratory acidosis (pH<7.30)).
Measured: 30 days of randomization.
Secondary outcomes (4)
Number of days on a ventilator.
weaning considered successful if patient is able to achieve the following within 48 hours: pH >7.35, Decrease in PaCO2 of >15-20%, PaO2>60 mmHg, SaO2> 90% on FiO2 <40%, Respiratory rate < 24 bpm and No signs of respiratory distress like agitation, diaphoresis or anxiety.
Measured: 30 days of randomization.
mortality.
Measured: 60 days of randomization.
Length of ICU stay in days.
duration of ICU stay from time of admission till discharge from ICU in days.
Measured: 60 days of randomization.
Length of hospital stay in days.
Measured: 60 days of randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Failure, ICUStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montaser Gamal Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montaser Gamal Ahmed, Assiut University
- Investigators
- Sahar Refaat Mahmoud, Principal investigator, Assuit university hospitalSarah Mohamed Hashem Hamza., Principal investigator, Assuit university hospitalEmad Zareef, Principal investigator, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698004
- Sponsor's protocol ID
- prone positioning in ICU
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
PubMed 30872586Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
PubMed 24134414
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05698004
- Acronym / sponsor ID
- prone positioning in ICU
- Conditions
- Respiratory Failure, ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Montaser Gamal AhmedUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.
Detailed description
we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.
| Arm | Type | Receives |
|---|---|---|
| Group-1: prone positioning + standard treatment | Active comparator | Other: prone positioningPatients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required. |
| Group-2: Standard treatment only | No intervention | –Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.
- had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| prone positioningThe target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. | Other | Group-1: prone positioning + standard treatment |
Primary outcome
Number of participants within intervention arm whom need endotracheal intubation.
Time frame: 30 days of randomization.
Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR> 35/min., PaO2/FiO2<200 mmHg, and respiratory acidosis (pH<7.30)).
4 secondary outcomes
Number of days on a ventilator.
Time frame: 30 days of randomization.
mortality.
Time frame: 60 days of randomization.
Length of ICU stay in days.
Time frame: 60 days of randomization.
Length of hospital stay in days.
Time frame: 60 days of randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 30872586Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
- Background: PubMed 24134414Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
Related trials for Respiratory Failure, ICU
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
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.
Aliae AR Mohamed Hussein contact
Sahar Refaat Mahmoud principal investigator
Assuit university hospital
Sarah Mohamed Hashem Hamza. principal investigator
Assuit university hospital
Emad Zareef principal investigator
Assuit university hospital
Questions about this trial
What is this clinical trial studying?
A study testing prone positioning in people with Respiratory Failure, ICU, run by Montaser Gamal Ahmed.
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 0 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Montaser Gamal (01008951058, montaser_zahran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants within intervention arm whom need endotracheal intubation. (time frame: 30 days of randomization.). 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 NCT05698004, which also lists 3 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 26 Jan 2023.