Fluid OverloadNCT05264454
Effect of High-Flow Nasal Cannula on IVC Measurements Using Point of Care Ultrasound
A study testing high flow nasal cannulae in people with Fluid Overload, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The size of the inferior vena cava (IVC) using point of care ultrasound is used in resuscitation of patients who are critically ill and is now being used as a standard part of resuscitation in many clinical situations. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Overload
- What is being tested?
- high flow nasal cannulae
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2022to 30 Jun 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ambulatory
- 18-40 years old
Who cannot join
- Severe lung disease (e.g. poorly controlled asthma, COPD with FEV1 <40%)
- Congestive heart failure (diastolic dysfunction, ejection fraction < 50%, severe valvular disorders)
- Renal failure
- Complete nasal obstruction or facial deformities
- BMI > 30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The size of the inferior vena cava (IVC) using point of care ultrasound is used in resuscitation of patients who are critically ill and is now being used as a standard part of resuscitation in many clinical situations. Multiple factors can effect the size of the IVC including the type of oxygen devices the patient is currently on. In the ICU setting, the use of High Flow Nasal Cannula (HFNC) is often used to help in patients who are critically ill. There is some evidence to suggest that the use of HFNC can effect the size of the IVC measurement but the extent of the effect has not been well characterized. The purpose of this study is to determine the effect HFNC has on the size of the IVC measured using a point of care ultrasound.
Read the detailed description
Shock is a state of decreased perfusion and inadequate oxygen delivery to tissues. This results in end organ damage and is associated with high morbidity and mortality, regardless of etiology. Shock associated with an infection is known as septic shock. In the intensive care unit (ICU) population, septic shock is the most common admission to the ICU and, with a mortality rate approaching 30%, is one of the leading causes of death. Early antibiotics and early intravenous fluid administration are a key component of resuscitation, but over-resuscitation with fluids is associated with adverse outcomes, including death. Therefore, methods to determine the ideal amount of fluid to administer are required.
Increasingly, the use of a bedside ultrasound, known as point of care ultrasound (PoCUS), can be used to determine the cause of shock and to help guide the ideal amount of fluid administration. One method for determining the appropriate amount of fluid to administer is the measurement of the size of the inferior vena cava (IVC). The IVC is a large vein that travels through the abdomen and delivers blood back to the heart. In a breathing patient, the size of the IVC varies with the breathing cycle. During inspiration the contraction of the diaphragm results in the generation of a negative pressure inside the chest cavity. This pressure change results in a decrease in size of the IVC during inspiration; contrary, during expiration, the IVC will be maximally distended. One of the best methods for determining fluid responsiveness using IVC is known as the IVC collapsibility index, which is defined as the [(Maximum diameter IVC-Minimum diameter) / Maximum diameter IVC] x 100. If the index is greater than 41% (range, 40%-42%), the LR ranged from 3.5 (95% CI, 1.1-15) to 9.3 (95% CI, 0.88-51) that the patient would respond to fluid.
One limitation to the use of PoCUS to assess the IVC is that the size of the vessel is affected by pressure inside the chest cavity. For example, patients who have obstructive sleep apnea (OSA) are often treated using a device called a continuous positive airway pressure (CPAP) machine. CPAP works by applying a constant amount of air pressure to prevent the soft tissues in the neck from collapsing and obstructing the airway. This constant pressure results in an increase of the chest cavity pressure which has been shown to increase the IVC diameter and a decreased IVC collapsibility index. This could result in an error in not administering fluid when the patient would benefit from it.
A patient population where this error may occur are those admitted to hospital with pneumonia. Pneumonia is the most common presentation of septic shock in critical care. Often times these patients present with septic shock as well as respiratory failure, which is treated with supplemental oxygen. Increasingly, high flow nasal cannulas (HFNC) have been used in the initial management of respiratory failure. Studies in the critically ill populations have demonstrated that, compared to conventional oxygen therapy, HFNC provides superior oxygenation and decreases the need for intubation. HFNC is a device that is able to generate very high flows (up to 60 L/min) at an adjustable FiO2 such that even at very high peak inspiratory flows (i.e. breathing in quickly), FiO2 remains consistent. These high flows generate a CPAP effect, with an approximately linear relationship of 1 cmH2O for every 10 L/min of flow. Therefore, it is possible that patients who are placed on HFNC may have an artificially enlarged IVC measurement by ultrasound.
Considering the increasing scope and utilization of PoCUS as well as HFNC in the treatment of respiratory failure, it is important to establish what effect HFNC has on POCUS IVC measurements. To date, only one study has examined the effect of HFNC on the size of IVC. This study was conducted in heart failure patients where the patients were all volume overloaded (distended IVC). The study placed patients in heart failure on HFNC on flows of 20 and 40L/min which resulted in a decrease in the IVC collapsibility index. However, no study has examined the effect of HFNC non-volume overloaded patients at 60L /min.
Our hypothesis is that the application of HFNC will increase in the size of the IVC and decrease the IVC collapsibility index in healthy patients.
- Conditions
- Fluid Overload
- Being tested
- high flow nasal cannulae
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaeDevice
Also called point of care ultrasound
The plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow
| Study group | Role | What they receive |
|---|---|---|
| 0 L | Placebo comparator | This will be the arm where the baseline IVC assessment size is conducted at Receives: Device: high flow nasal cannulae |
| 30 L | Active comparator | The HFNC flow will be set at 30 L / min. The IVC size will then be assessed using a POCUS Receives: Device: high flow nasal cannulae |
| 60 L | Active comparator | The HFNC flow will be set at 60 L / min. The IVC size will then be assessed using a POCUS Receives: Device: high flow nasal cannulae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior vena cava maximal diameter in millimeter
Measured: 3 minutes after the intervention
Secondary outcomes (1)
Inferior vena cava maximal collapsibility index
[(Maximum diameter Inferior vena cava -Minimum diameter) / Maximum diameter Inferior vena cava] x 100
Measured: 3 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: due to Covid-19 the project will not be moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264454
- Sponsor's protocol ID
- HFNCIVC1
- Status last verified
- Aug 2024
- First submitted
- 2 Dec 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.
PubMed 24499231Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
PubMed 23984731Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675Navaneelan T. Deaths involving sepsis in Canada. Health at a Glance. 2016;(82):11.
Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.
PubMed 24335434Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.
PubMed 28130687Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
PubMed 28101605National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
PubMed 16714767Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.
PubMed 29427013Perera P, Mailhot T, Riley D, Mandavia D. The RUSH exam: Rapid Ultrasound in SHock in the evaluation of the critically lll. Emerg Med Clin North Am. 2010 Feb;28(1):29-56, vii. doi: 10.1016/j.emc.2009.09.010.
PubMed 19945597Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.
PubMed 27673307Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
PubMed 23043910Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.
PubMed 26563768Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Jenkinson C, Davies RJ, Mullins R, Stradling JR. Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial. Lancet. 1999 Jun 19;353(9170):2100-5. doi: 10.1016/S0140-6736(98)10532-9.
PubMed 10382693
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Flow Nasal Cannula on IVC Measurements Using Point of Care Ultrasound
- ClinicalTrials.gov ID
- NCT05264454
- Acronym / sponsor ID
- HFNCIVC1
- Conditions
- Fluid Overload
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to Covid-19 the project will not be moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Mar 2022 (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 size of the inferior vena cava (IVC) using point of care ultrasound is used in resuscitation of patients who are critically ill and is now being used as a standard part of resuscitation in many clinical situations. Multiple factors can effect the size of the IVC including the type of oxygen devices the patient is currently on. In the ICU setting, the use of High Flow Nasal Cannula (HFNC) is often used to help in patients who are critically ill. There is some evidence to suggest that the use of HFNC can effect the size of the IVC measurement but the extent of the effect has not been well characterized. The purpose of this study is to determine the effect HFNC has on the size of the IVC measured using a point of care ultrasound.
Detailed description
Shock is a state of decreased perfusion and inadequate oxygen delivery to tissues. This results in end organ damage and is associated with high morbidity and mortality, regardless of etiology. Shock associated with an infection is known as septic shock. In the intensive care unit (ICU) population, septic shock is the most common admission to the ICU and, with a mortality rate approaching 30%, is one of the leading causes of death. Early antibiotics and early intravenous fluid administration are a key component of resuscitation, but over-resuscitation with fluids is associated with adverse outcomes, including death. Therefore, methods to determine the ideal amount of fluid to administer are required.
Increasingly, the use of a bedside ultrasound, known as point of care ultrasound (PoCUS), can be used to determine the cause of shock and to help guide the ideal amount of fluid administration. One method for determining the appropriate amount of fluid to administer is the measurement of the size of the inferior vena cava (IVC). The IVC is a large vein that travels through the abdomen and delivers blood back to the heart. In a breathing patient, the size of the IVC varies with the breathing cycle. During inspiration the contraction of the diaphragm results in the generation of a negative pressure inside the chest cavity. This pressure change results in a decrease in size of the IVC during inspiration; contrary, during expiration, the IVC will be maximally distended. One of the best methods for determining fluid responsiveness using IVC is known as the IVC collapsibility index, which is defined as the [(Maximum diameter IVC-Minimum diameter) / Maximum diameter IVC] x 100. If the index is greater than 41% (range, 40%-42%), the LR ranged from 3.5 (95% CI, 1.1-15) to 9.3 (95% CI, 0.88-51) that the patient would respond to fluid.
One limitation to the use of PoCUS to assess the IVC is that the size of the vessel is affected by pressure inside the chest cavity. For example, patients who have obstructive sleep apnea (OSA) are often treated using a device called a continuous positive airway pressure (CPAP) machine. CPAP works by applying a constant amount of air pressure to prevent the soft tissues in the neck from collapsing and obstructing the airway. This constant pressure results in an increase of the chest cavity pressure which has been shown to increase the IVC diameter and a decreased IVC collapsibility index. This could result in an error in not administering fluid when the patient would benefit from it.
A patient population where this error may occur are those admitted to hospital with pneumonia. Pneumonia is the most common presentation of septic shock in critical care. Often times these patients present with septic shock as well as respiratory failure, which is treated with supplemental oxygen. Increasingly, high flow nasal cannulas (HFNC) have been used in the initial management of respiratory failure. Studies in the critically ill populations have demonstrated that, compared to conventional oxygen therapy, HFNC provides superior oxygenation and decreases the need for intubation. HFNC is a device that is able to generate very high flows (up to 60 L/min) at an adjustable FiO2 such that even at very high peak inspiratory flows (i.e. breathing in quickly), FiO2 remains consistent. These high flows generate a CPAP effect, with an approximately linear relationship of 1 cmH2O for every 10 L/min of flow. Therefore, it is possible that patients who are placed on HFNC may have an artificially enlarged IVC measurement by ultrasound.
Considering the increasing scope and utilization of PoCUS as well as HFNC in the treatment of respiratory failure, it is important to establish what effect HFNC has on POCUS IVC measurements. To date, only one study has examined the effect of HFNC on the size of IVC. This study was conducted in heart failure patients where the patients were all volume overloaded (distended IVC). The study placed patients in heart failure on HFNC on flows of 20 and 40L/min which resulted in a decrease in the IVC collapsibility index. However, no study has examined the effect of HFNC non-volume overloaded patients at 60L /min.
Our hypothesis is that the application of HFNC will increase in the size of the IVC and decrease the IVC collapsibility index in healthy patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 L | Placebo comparator | Device: high flow nasal cannulaeThis will be the arm where the baseline IVC assessment size is conducted at |
| 30 L | Active comparator | Device: high flow nasal cannulaeThe HFNC flow will be set at 30 L / min. The IVC size will then be assessed using a POCUS |
| 60 L | Active comparator | Device: high flow nasal cannulaeThe HFNC flow will be set at 60 L / min. The IVC size will then be assessed using a POCUS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ambulatory
- 18-40 years old
Key exclusion criteria (6 listed)
- Severe lung disease (e.g. poorly controlled asthma, COPD with FEV1 <40%)
- Congestive heart failure (diastolic dysfunction, ejection fraction < 50%, severe valvular disorders)
- Renal failure
- Complete nasal obstruction or facial deformities
- BMI > 30
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 |
|---|---|---|
| high flow nasal cannulaeAlso: point of care ultrasoundThe plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow | Device | 0 L, 30 L, 60 L |
Primary outcome
Inferior vena cava maximal diameter in millimeter
Time frame: 3 minutes after the intervention
1 secondary outcome
Inferior vena cava maximal collapsibility index
Time frame: 3 minutes after the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 24499231Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.
- Background: PubMed 23984731Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
- Background: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
- BackgroundNavaneelan T. Deaths involving sepsis in Canada. Health at a Glance. 2016;(82):11.
- Background: PubMed 24335434Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.
- Background: PubMed 28130687Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.
- Background: PubMed 28101605Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Background: PubMed 16714767National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
- Background: PubMed 29427013Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.
- Background: PubMed 19945597Perera P, Mailhot T, Riley D, Mandavia D. The RUSH exam: Rapid Ultrasound in SHock in the evaluation of the critically lll. Emerg Med Clin North Am. 2010 Feb;28(1):29-56, vii. doi: 10.1016/j.emc.2009.09.010.
- Background: PubMed 27673307Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.
- Background: PubMed 23043910Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
- 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.
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 high flow nasal cannulae in people with Fluid Overload, run by Nova Scotia Health Authority at 1 site in Canada.
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 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Inferior vena cava maximal diameter in millimeter (time frame: 3 minutes after the intervention). 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 NCT05264454, which also lists 18 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 21 Aug 2024.