COVID-19 PneumoniaNCT05045885
Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Supported by ECMO
An observational study of COVID-19 Pneumonia and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation Complication, Tracheostomy Complication
- How many people
- 32 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2020to 1 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: The COVID and non-COVID patients on VV ECMO who underwent percutaneous dilatational tracheostomy (PDT).
Who may be able to join
- over 18-years old.
Who cannot join
- less than 18 years old,
- Pregnancy
- VA-ECMO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Disease Supported by Extracorporeal Membrane Oxygenation.
COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. The latter group, albeit represent less than 10% of all SARS-CoV-2 infections will require ICU admission, multi-modal organ support including Extracorporeal Membrane Oxygenation (ECMO) for severe refractory cardiac and/or pulmonary failure.
Prolonged mechanical ventilation is a typical indication for tracheostomy. Percutaneous tracheostomy at the bedside has several advantages over surgical tracheostomy. However, with the emerging pandemic, there is a lack of literature regarding the safety of percutaneous bedside tracheostomy for patients with COVID-19 supported by ECMO.
Our study aims to describe the safety of bedside percutaneous dilatational tracheostomy of confirmed COVID-19 positive patients supported on ECMO.
Read the detailed description
At the time of writing, more than 50 million confirmed cases of COVID-19 have been reported worldwide with over one million reported deaths1 Data about ICU mortality is variable and may be affected by the infrastructure of the health care system in each country, however, the estimated mortality rate in COVID-19 patients who need ICU is 25.7%-35.7%2.
The World Health Organization (WHO) suggests ECMO for COVID-19 patients with severe ARDS not responding to conventional treatment. However, Extracorporeal Life Support Organization (ESLSO) guidance recommends a balance of resource utilization, allocation, and appropriate case selection3.
According to ELSO Registry; 3048 COVID-19 cases have been supported on ECMO. Interestingly discharge alive rate was reported to be over 60%4.
Tracheostomy can be performed with two different techniques. Open 'surgical' tracheostomy (OT) and percutaneous dilatational tracheostomy (PDT). The later was favored during the SARS outbreak (SARS-CoV-1). However, the literature is not clear yet about the preferable and safest technique during Covid-19 disease SARS-CoV-2 as both procedures could be aerosol-generating procedures (AGP)5,6.
SARS-CoV-2 is highly contagious and can spread via aerosol, contact, and droplet. This poses a significant risk to health care workers (HCW) and in particular during airway interventions and procedures.
The optimal time to perform tracheostomy in COVID-19 patients remains controversial. Recommendations are different whether early or late tracheostomy is the preferred one, however, the American Academy of Otolaryngology-Head and Neck surgery recommend the procedure to take a place 2-3 weeks after intubation5,6.
Generally speaking, tracheostomy has many advantages in critically ill patients such as reducing the days of mechanical ventilation, reduce ICU admission, reduce nosocomial pneumonia in special groups7,8.
Tracheostomy carries the second-highest risk of transmission of infection to staff after endotracheal intubation. PDT in patients supported on ECMO is not without risks. Bleeding is a major concern and has been reported at 40%9-11. Other reported procedural complications are mechanical and ECMO-circuit dysfunction9-12.
The literature search revealed one case series from the UK13 of PDT in the same patient population as our study. However, the report focuses on the description of the procedure rather than the safety aspect. To my knowledge, this is the first study to look in-depth into staff and patient safety of PDT in COVID-19 positive patients on ECMO support.
- Conditions
- COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation Complication, Tracheostomy Complication, Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
External or endotracheal bleeding (mild, moderate, sever)
Mild: Minimal external or endotracheal bleeding with minimal or no drop-in haemoglobin and no surgical intervention.
Moderate: Obvious external or endotracheal bleed. A drop-in haemoglobin of less than one gram/dL or transfusion of one unit of red blood cells.
Severe bleeding: a drop of two grams or more in haemoglobin/dL and/or transfusion of two or more red cell packs or other blood products, disseminated intravascular coagulopathy (DIC) or need for surgical intervention
Measured: 24 hours Post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Mar 2020
- Primary completion30 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Labib, Principal investigator, Hamad Medical Corporation - HMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045885
- Sponsor's protocol ID
- MRC-01-20-1196
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval of Hospital IRB
Publications
WHO Director-General's opening remarks at the media briefing on COVID-19: 11 March 2020. Published March 11, 2020
COVID Live Update: 189,294,523 Cases and 4,076,726 Deaths from the Coronavirus - Worldometer. Worldometers.info. https://www.worldometers.info/coronavirus/. Published 2021. Accessed July 15, 2021.
Extracorporeal Life Support Organization - ECMO and ECLS. Elso.org. https://www.elso.org/COVID19.aspx. Published 2021. Accessed June 9, 2021.
Tracheotomy Recommendations During the COVID-19 Pandemic - American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). https://www.entnet.org/resource/tracheotomy-recommendations-during-the-covid-19-pandemic-2/. Published 2021. Accessed June 9, 2021.
Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.
PubMed 32167538Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
PubMed 32250385Auld SC, Caridi-Scheible M, Blum JM, Robichaux C, Kraft C, Jacob JT, Jabaley CS, Carpenter D, Kaplow R, Hernandez-Romieu AC, Adelman MW, Martin GS, Coopersmith CM, Murphy DJ; and the Emory COVID-19 Quality and Clinical Research Collaborative. ICU and Ventilator Mortality Among Critically Ill Adults With Coronavirus Disease 2019. Crit Care Med. 2020 Sep;48(9):e799-e804. doi: 10.1097/CCM.0000000000004457.
PubMed 32452888Shekar K, Badulak J, Peek G, Boeken U, Dalton HJ, Arora L, Zakhary B, Ramanathan K, Starr J, Akkanti B, Antonini MV, Ogino MT, Raman L, Barret N, Brodie D, Combes A, Lorusso R, MacLaren G, Muller T, Paden M, Pellegrino V; ELSO Guideline Working Group. Extracorporeal Life Support Organization Coronavirus Disease 2019 Interim Guidelines: A Consensus Document from an International Group of Interdisciplinary Extracorporeal Membrane Oxygenation Providers. ASAIO J. 2020 Jul;66(7):707-721. doi: 10.1097/MAT.0000000000001193.
PubMed 32604322Nieszkowska A, Combes A, Luyt CE, Ksibi H, Trouillet JL, Gibert C, Chastre J. Impact of tracheotomy on sedative administration, sedation level, and comfort of mechanically ventilated intensive care unit patients. Crit Care Med. 2005 Nov;33(11):2527-33. doi: 10.1097/01.ccm.0000186898.58709.aa.
PubMed 16276177Dempsey GA, Grant CA, Jones TM. Percutaneous tracheostomy: a 6 yr prospective evaluation of the single tapered dilator technique. Br J Anaesth. 2010 Dec;105(6):782-8. doi: 10.1093/bja/aeq238. Epub 2010 Sep 2.
PubMed 20813838Beiderlinden M, Eikermann M, Lehmann N, Adamzik M, Peters J. Risk factors associated with bleeding during and after percutaneous dilational tracheostomy. Anaesthesia. 2007 Apr;62(4):342-6. doi: 10.1111/j.1365-2044.2007.04979.x.
PubMed 17381569Tang S, Mao Y, Jones RM, Tan Q, Ji JS, Li N, Shen J, Lv Y, Pan L, Ding P, Wang X, Wang Y, MacIntyre CR, Shi X. Aerosol transmission of SARS-CoV-2? Evidence, prevention and control. Environ Int. 2020 Nov;144:106039. doi: 10.1016/j.envint.2020.106039. Epub 2020 Aug 7.
PubMed 32822927Weissman DN, de Perio MA, Radonovich LJ Jr. COVID-19 and Risks Posed to Personnel During Endotracheal Intubation. JAMA. 2020 May 26;323(20):2027-2028. doi: 10.1001/jama.2020.6627. No abstract available.
PubMed 32338710Chorath K, Hoang A, Rajasekaran K, Moreira A. Association of Early vs Late Tracheostomy Placement With Pneumonia and Ventilator Days in Critically Ill Patients: A Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):450-459. doi: 10.1001/jamaoto.2021.0025.
PubMed 33704354Zangrillo A, Landoni G, Biondi-Zoccai G, Greco M, Greco T, Frati G, Patroniti N, Antonelli M, Pesenti A, Pappalardo F. A meta-analysis of complications and mortality of extracorporeal membrane oxygenation. Crit Care Resusc. 2013 Sep;15(3):172-8.
PubMed 23944202
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Disease Supported by Extracorporeal Membrane Oxygenation.
- ClinicalTrials.gov ID
- NCT05045885
- Acronym / sponsor ID
- MRC-01-20-1196
- Conditions
- COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation Complication, Tracheostomy Complication, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Sep 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.
COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. The latter group, albeit represent less than 10% of all SARS-CoV-2 infections will require ICU admission, multi-modal organ support including Extracorporeal Membrane Oxygenation (ECMO) for severe refractory cardiac and/or pulmonary failure.
Prolonged mechanical ventilation is a typical indication for tracheostomy. Percutaneous tracheostomy at the bedside has several advantages over surgical tracheostomy. However, with the emerging pandemic, there is a lack of literature regarding the safety of percutaneous bedside tracheostomy for patients with COVID-19 supported by ECMO.
Our study aims to describe the safety of bedside percutaneous dilatational tracheostomy of confirmed COVID-19 positive patients supported on ECMO.
Detailed description
At the time of writing, more than 50 million confirmed cases of COVID-19 have been reported worldwide with over one million reported deaths1 Data about ICU mortality is variable and may be affected by the infrastructure of the health care system in each country, however, the estimated mortality rate in COVID-19 patients who need ICU is 25.7%-35.7%2.
The World Health Organization (WHO) suggests ECMO for COVID-19 patients with severe ARDS not responding to conventional treatment. However, Extracorporeal Life Support Organization (ESLSO) guidance recommends a balance of resource utilization, allocation, and appropriate case selection3.
According to ELSO Registry; 3048 COVID-19 cases have been supported on ECMO. Interestingly discharge alive rate was reported to be over 60%4.
Tracheostomy can be performed with two different techniques. Open 'surgical' tracheostomy (OT) and percutaneous dilatational tracheostomy (PDT). The later was favored during the SARS outbreak (SARS-CoV-1). However, the literature is not clear yet about the preferable and safest technique during Covid-19 disease SARS-CoV-2 as both procedures could be aerosol-generating procedures (AGP)5,6.
SARS-CoV-2 is highly contagious and can spread via aerosol, contact, and droplet. This poses a significant risk to health care workers (HCW) and in particular during airway interventions and procedures.
The optimal time to perform tracheostomy in COVID-19 patients remains controversial. Recommendations are different whether early or late tracheostomy is the preferred one, however, the American Academy of Otolaryngology-Head and Neck surgery recommend the procedure to take a place 2-3 weeks after intubation5,6.
Generally speaking, tracheostomy has many advantages in critically ill patients such as reducing the days of mechanical ventilation, reduce ICU admission, reduce nosocomial pneumonia in special groups7,8.
Tracheostomy carries the second-highest risk of transmission of infection to staff after endotracheal intubation. PDT in patients supported on ECMO is not without risks. Bleeding is a major concern and has been reported at 40%9-11. Other reported procedural complications are mechanical and ECMO-circuit dysfunction9-12.
The literature search revealed one case series from the UK13 of PDT in the same patient population as our study. However, the report focuses on the description of the procedure rather than the safety aspect. To my knowledge, this is the first study to look in-depth into staff and patient safety of PDT in COVID-19 positive patients on ECMO support.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The COVID and non-COVID patients on VV ECMO who underwent percutaneous dilatational tracheostomy (PDT).
Key inclusion criteria (1 listed)
- over 18-years old.
Key exclusion criteria (3 listed)
- less than 18 years old,
- Pregnancy
- VA-ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
External or endotracheal bleeding (mild, moderate, sever)
Time frame: 24 hours Post procedure
Mild: Minimal external or endotracheal bleeding with minimal or no drop-in haemoglobin and no surgical intervention. Moderate: Obvious external or endotracheal bleed. A drop-in haemoglobin of less than one gram/dL or transfusion of one unit of red blood cells. Severe bleeding: a drop of two grams or more in haemoglobin/dL and/or transfusion of two or more red cell packs or other blood products, disseminated intravascular coagulopathy (DIC) or need for surgical intervention
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 16 Sep 2021.
- BackgroundWHO Director-General's opening remarks at the media briefing on COVID-19: 11 March 2020. Published March 11, 2020
- BackgroundCOVID Live Update: 189,294,523 Cases and 4,076,726 Deaths from the Coronavirus - Worldometer. Worldometers.info. https://www.worldometers.info/coronavirus/. Published 2021. Accessed July 15, 2021.
- BackgroundExtracorporeal Life Support Organization - ECMO and ECLS. Elso.org. https://www.elso.org/COVID19.aspx. Published 2021. Accessed June 9, 2021.
- BackgroundTracheotomy Recommendations During the COVID-19 Pandemic - American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). https://www.entnet.org/resource/tracheotomy-recommendations-during-the-covid-19-pandemic-2/. Published 2021. Accessed June 9, 2021.
- Results publication: PubMed 32167538Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.
- Results publication: PubMed 32250385Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
- Results publication: PubMed 32452888Auld SC, Caridi-Scheible M, Blum JM, Robichaux C, Kraft C, Jacob JT, Jabaley CS, Carpenter D, Kaplow R, Hernandez-Romieu AC, Adelman MW, Martin GS, Coopersmith CM, Murphy DJ; and the Emory COVID-19 Quality and Clinical Research Collaborative. ICU and Ventilator Mortality Among Critically Ill Adults With Coronavirus Disease 2019. Crit Care Med. 2020 Sep;48(9):e799-e804. doi: 10.1097/CCM.0000000000004457.
- Results publication: PubMed 32604322Shekar K, Badulak J, Peek G, Boeken U, Dalton HJ, Arora L, Zakhary B, Ramanathan K, Starr J, Akkanti B, Antonini MV, Ogino MT, Raman L, Barret N, Brodie D, Combes A, Lorusso R, MacLaren G, Muller T, Paden M, Pellegrino V; ELSO Guideline Working Group. Extracorporeal Life Support Organization Coronavirus Disease 2019 Interim Guidelines: A Consensus Document from an International Group of Interdisciplinary Extracorporeal Membrane Oxygenation Providers. ASAIO J. 2020 Jul;66(7):707-721. doi: 10.1097/MAT.0000000000001193.
- Results publication: PubMed 16276177Nieszkowska A, Combes A, Luyt CE, Ksibi H, Trouillet JL, Gibert C, Chastre J. Impact of tracheotomy on sedative administration, sedation level, and comfort of mechanically ventilated intensive care unit patients. Crit Care Med. 2005 Nov;33(11):2527-33. doi: 10.1097/01.ccm.0000186898.58709.aa.
- Results publication: PubMed 20813838Dempsey GA, Grant CA, Jones TM. Percutaneous tracheostomy: a 6 yr prospective evaluation of the single tapered dilator technique. Br J Anaesth. 2010 Dec;105(6):782-8. doi: 10.1093/bja/aeq238. Epub 2010 Sep 2.
- Results publication: PubMed 17381569Beiderlinden M, Eikermann M, Lehmann N, Adamzik M, Peters J. Risk factors associated with bleeding during and after percutaneous dilational tracheostomy. Anaesthesia. 2007 Apr;62(4):342-6. doi: 10.1111/j.1365-2044.2007.04979.x.
- Results publication: PubMed 32822927Tang S, Mao Y, Jones RM, Tan Q, Ji JS, Li N, Shen J, Lv Y, Pan L, Ding P, Wang X, Wang Y, MacIntyre CR, Shi X. Aerosol transmission of SARS-CoV-2? Evidence, prevention and control. Environ Int. 2020 Nov;144:106039. doi: 10.1016/j.envint.2020.106039. Epub 2020 Aug 7.
- Individual participant dataSharing planned: Yes. After approval of Hospital IRB
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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.
Ahmed Labib principal investigator
Hamad Medical Corporation - HMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
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 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 16 Sep 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 Qatar. 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?
External or endotracheal bleeding (mild, moderate, sever) (time frame: 24 hours Post procedure). 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 NCT05045885, which also lists 22 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 16 Sep 2021.