Ventilation and OxygenationNCT04376047
Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients
A study testing Reverse Trendelenburg position and Semi-recumbent position in people with Ventilation and Oxygenation and Obese; Positioning, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventilation and Oxygenation, Obese; Positioning, Critically Ill
- What is being tested?
- Reverse Trendelenburg position and Semi-recumbent position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2020to 12 Mar 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- body mass index ≥ 30
- Mechanically ventilated
Who cannot join
- Trauma
- Shock
- Acute respiratory distress syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial
The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients
Read the detailed description
Obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. It is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. This trial was conducted in four general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse Trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. Patients were positioned in the study positions 4 times per day. Patients were maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.
- Being tested
- Reverse Trendelenburg position, Semi-recumbent position
- Keywords
- Reverse Trendelenburg position, semi-recumbent position, ventilation, oxygenation, obese patients
- Medical subject headings
- Respiratory Aspiration, Obesity, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Trendelenburg positionOther
The Reverse Trendelenburg position is a position in which patients' hip and knee are not flexed but the head and chest are elevated at 30° than the abdomen and legs.
Semi-recumbent positionOther
The semi-recumbent position is an upright positioning of the head and torso at an angle of 45° while legs are lying on the bed.
| Study group | Role | What they receive |
|---|---|---|
| Reverse Trendelenburg position group | Experimental | Obese critically ill patients who are positioned in reverse Trendelenburg position Receives: Other: Reverse Trendelenburg position |
| Semi-recumbent position group | Active comparator | Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position Receives: Other: Semi-recumbent position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory dynamic compliance
Respiratory dynamic compliance (Cdyn) in ml/cm H2O is the change in lung volume per unit change in pressure in the presence of flow. It is calculated through the equation of tidal volume/ (peak inspiratory pressure - positive end expiatory pressure). All the previous equation variables are assessed from the patient's mechanical ventilator data.
Measured: 30 minute form positioning time
Respiratory minute volume
Respiratory minute volume (VE) in mL/min is the total volume of air that is expired over one minute. It is calculated directly by the mechanical ventilator and presented on patient's mechanical ventilator data.
Measured: 30 minute form positioning time
Partial pressure carbon dioxide
Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.
Measured: 30 minute form positioning time
Partial pressure oxygen
Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.
Measured: 30 minute form positioning time
Hypoxemic index
Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).
Measured: 30 minute form positioning time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start13 Jan 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation and OxygenationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-group pre-test and repeated post-test study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376047
- Sponsor's protocol ID
- 1212020
- Status last verified
- May 2020
- First submitted
- 18 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04376047
- Acronym / sponsor ID
- 1212020
- Keywords
- Reverse Trendelenburg position, semi-recumbent position, ventilation, oxygenation, obese patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 6 May 2020 (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.
The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients
Detailed description
Obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. It is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. This trial was conducted in four general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse Trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. Patients were positioned in the study positions 4 times per day. Patients were maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- two-group pre-test and repeated post-test study
| Arm | Type | Receives |
|---|---|---|
| Reverse Trendelenburg position group | Experimental | Other: Reverse Trendelenburg positionObese critically ill patients who are positioned in reverse Trendelenburg position |
| Semi-recumbent position group | Active comparator | Other: Semi-recumbent positionObese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index ≥ 30
- Mechanically ventilated
Key exclusion criteria (3 listed)
- Trauma
- Shock
- Acute respiratory distress syndrome
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 |
|---|---|---|
| Reverse Trendelenburg positionThe Reverse Trendelenburg position is a position in which patients' hip and knee are not flexed but the head and chest are elevated at 30° than the abdomen and legs. | Other | Reverse Trendelenburg position group |
| Semi-recumbent positionThe semi-recumbent position is an upright positioning of the head and torso at an angle of 45° while legs are lying on the bed. | Other | Semi-recumbent position group |
Primary outcome
Respiratory dynamic compliance
Time frame: 30 minute form positioning time
Respiratory dynamic compliance (Cdyn) in ml/cm H2O is the change in lung volume per unit change in pressure in the presence of flow. It is calculated through the equation of tidal volume/ (peak inspiratory pressure - positive end expiatory pressure). All the previous equation variables are assessed from the patient's mechanical ventilator data.
Respiratory minute volume
Time frame: 30 minute form positioning time
Respiratory minute volume (VE) in mL/min is the total volume of air that is expired over one minute. It is calculated directly by the mechanical ventilator and presented on patient's mechanical ventilator data.
Partial pressure carbon dioxide
Time frame: 30 minute form positioning time
Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.
Partial pressure oxygen
Time frame: 30 minute form positioning time
Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.
Hypoxemic index
Time frame: 30 minute form positioning time
Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).
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 6 May 2020.
- Individual participant dataSharing planned: Undecided. Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Trendelenburg position and Semi-recumbent position in people with Ventilation and Oxygenation and Obese; Positioning, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 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 6 May 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory dynamic compliance (time frame: 30 minute form positioning time). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.