Pulmonary MicroaspirationNCT04831489
Microaspiration in ERCP
An observational study of Pulmonary Microaspiration, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Microaspiration
- What is being tested?
- Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to Feb 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: the population of the study will be randomly selected from the daily scheduled cases undergoing ERCP in the Gastroenterology department of Theodor Bilhrarz research institute.
Who may be able to join
- ASA 1-3.
- Age above 18 years old.
- Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) -
Who cannot join
- Age < 18 years.
- Morbid obesity BMI ≥ 40 Kg/ m2.
- Pregnancy.
- Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4
- A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid.
- Patients in the intensive care unit and/or requiring mechanical ventilation prior to the procedure.
Show all 11Show fewer
- Previously intubated patients during the same hospitalization.
- Tracheostomized patients.
- Patients with swallowing disorders.
- Bowel obstruction.
- Anticipated difficult intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment.
Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity.
Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge.
Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients.
According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks.
For ERCP cases, which can be very challenging, few studies have addressed what is the best anesthetic choice, i.e. deep sedation or general anesthesia with intubation. Significant complications such as aspiration, hypoxemia, and hypotension are potential risks in patients undergoing ERCP procedures, and important factors that can modify these events' severity include patients' ASA status, patients' hydration and oxygenation status, and monitoring techniques used during the procedure.
Perioperative pulmonary aspiration (POPA) may lead to clinically significant morbidities and/or mortality. The risk factors for pulmonary aspiration are usually overlooked unless the patient has a history of gastrointestinal diseases (for example gastroesophageal reflux disease, upper gastrointestinal bleeding, or intestinal obstruction). However, aspiration pneumonia is seldom observed in healthy patients undergoing regular endoscopy. On the other hand, prolonged or difficult procedures may be associated with increased risks of regurgitation and aspiration.
Apparent aspiration is a notable adverse event during gastrointestinal endoscopy, on the other hand, microaspiration is an underreported complication, and data about it is scarce. Since hypoxemia is a common manifestation of pulmonary aspiration and pulse oximetry monitoring is a routine practice, therefore, postoperative hypoxemia (POH) can be used as a potential signal for POPA.
There is no conclusive data to support or refuse the need for endotracheal intubation to avoid microaspiration during ERCP; therefore, the participants in the study decided to prospectively compare both techniques as regards the risk of microaspiration.
- Conditions
- Pulmonary Microaspiration
- Being tested
- Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingRadiation
pre and postoperative CT scan of lung
| Study group | Role | What they receive |
|---|---|---|
| deep sedation | Anesthesia will be induced using titrated doses of propofol (0.5-1.5 mg/kg) and fentanyl (25-50 μg) initially to carefully maintain spontaneous breathing yet maintaining airway patency. Once adequate jaw relaxation is achieved, the endoscopy probe will be inserted. Maintenance of sedation will be carried out using propofol infusion between 80-120 mcg/kg/min. Additional dose 25-50 mg propofol will be given to the patient if spontaneous movement occurs Receives: Radiation: Imaging | |
| Genral anesthesia | After mask pre-oxygenation, anesthesia will be induced with (2 mg/kg) propofol and (1 μg /kg) fentanyl. The neuromuscular blockade will be achieved with (0.5 mg/kg) atracurium followed by tracheal intubation. Anesthesia will be maintained to keep the end-tidal anesthetic concentrations within 1 MAC for sevoflurane.
The neuromuscular blockade will be maintained with intermittent doses of atracurium (0.1mg/kg). Mechanical ventilation is adjusted with fresh gas flow oxygen in air 30-40% at a rate of 2 L/min to maintain end-tidal carbon dioxide of 35-40 mm Hg. Reversal of neuromuscular blockade will be achieved by intravenous administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Receives: Radiation: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
POPA
Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Number of intraoperative hypoxic episodes.
Number of intraoperative hypoxic episodes in postoperative period
Measured: 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary MicroaspirationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831489
- Sponsor's protocol ID
- Microaspiration in ERCP
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shah SK, Mutignani M, Costamagna G. Therapeutic biliary endoscopy. Endoscopy. 2002 Jan;34(1):43-53. doi: 10.1055/s-2002-19395.
PubMed 11778129Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol. 2016 Oct-Dec;29(4):530-535. doi: 10.20524/aog.2016.0071. Epub 2016 Jul 14.
PubMed 27708522Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139.
PubMed 23635608Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.
PubMed 21295639Sorser SA, Fan DS, Tommolino EE, Gamara RM, Cox K, Chortkoff B, Adler DG. Complications of ERCP in patients undergoing general anesthesia versus MAC. Dig Dis Sci. 2014 Mar;59(3):696-7. doi: 10.1007/s10620-013-2932-2. Epub 2013 Nov 8. No abstract available.
PubMed 24202650Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.
PubMed 23877477
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Pulmonary Micro-aspiration in Intubated vs Sedated Patients Undergoing ERCP
- ClinicalTrials.gov ID
- NCT04831489
- Acronym / sponsor ID
- Microaspiration in ERCP
- Conditions
- Pulmonary Microaspiration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 5 Apr 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.
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge. apparent aspiration is noticeable however microaspiration is hard to detect clinically. our study aims at determining whether general anesthesia with endotracheal intubation or deep sedation is safer in ERCP patients.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard in diagnosing and treating biliary and pancreatic diseases. In fact, with the wide use of ERCP, many critical patients in whom conventional surgery was a high-risk procedure could be managed by endoscopic treatment.
Compared to other endoscopic procedures, ERCP is considered a relatively longer and more complex one, with a substantially higher complication rate. Anesthetic techniques must facilitate the success of this procedure without adding to morbidity.
Patients planned for ERCP often have additional comorbidities that make them high-risk candidates for general anesthesia so; the optimized choice of the anesthetic technique represents a real challenge.
Many anesthetic techniques are used, ranging from conscious sedation to general anesthesia. The worldwide accepted method is deep sedation in the presence of an anesthetist without endotracheal intubation. Intubation is recommended in very exceptional cases, for example is morbidly obese patients.
According to some authors, general anesthesia is less used as an anesthetic technique in ERCP; drawbacks of GA include: the lengthier time required for induction of and recovery from anesthesia which affects patients' turnover, the risk of residual neuromuscular blockade, the higher cost as well as ERCP is usually a day case procedure favoring the sedation technique. On the other hand, monitored anesthesia care or deep sedation in remote locations can avoid these drawbacks.
For ERCP cases, which can be very challenging, few studies have addressed what is the best anesthetic choice, i.e. deep sedation or general anesthesia with intubation. Significant complications such as aspiration, hypoxemia, and hypotension are potential risks in patients undergoing ERCP procedures, and important factors that can modify these events' severity include patients' ASA status, patients' hydration and oxygenation status, and monitoring techniques used during the procedure.
Perioperative pulmonary aspiration (POPA) may lead to clinically significant morbidities and/or mortality. The risk factors for pulmonary aspiration are usually overlooked unless the patient has a history of gastrointestinal diseases (for example gastroesophageal reflux disease, upper gastrointestinal bleeding, or intestinal obstruction). However, aspiration pneumonia is seldom observed in healthy patients undergoing regular endoscopy. On the other hand, prolonged or difficult procedures may be associated with increased risks of regurgitation and aspiration.
Apparent aspiration is a notable adverse event during gastrointestinal endoscopy, on the other hand, microaspiration is an underreported complication, and data about it is scarce. Since hypoxemia is a common manifestation of pulmonary aspiration and pulse oximetry monitoring is a routine practice, therefore, postoperative hypoxemia (POH) can be used as a potential signal for POPA.
There is no conclusive data to support or refuse the need for endotracheal intubation to avoid microaspiration during ERCP; therefore, the participants in the study decided to prospectively compare both techniques as regards the risk of microaspiration.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep sedation | – | Radiation: ImagingAnesthesia will be induced using titrated doses of propofol (0.5-1.5 mg/kg) and fentanyl (25-50 μg) initially to carefully maintain spontaneous breathing yet maintaining airway patency. Once adequate jaw relaxation is achieved, the endoscopy probe will be inserted. Maintenance of sedation will be carried out using propofol infusion between 80-120 mcg/kg/min. Additional dose 25-50 mg propofol will be given to the patient if spontaneous movement occurs |
| Genral anesthesia | – | Radiation: ImagingAfter mask pre-oxygenation, anesthesia will be induced with (2 mg/kg) propofol and (1 μg /kg) fentanyl. The neuromuscular blockade will be achieved with (0.5 mg/kg) atracurium followed by tracheal intubation. Anesthesia will be maintained to keep the end-tidal anesthetic concentrations within 1 MAC for sevoflurane. The neuromuscular blockade will be maintained with intermittent doses of atracurium (0.1mg/kg). Mechanical ventilation is adjusted with fresh gas flow oxygen in air 30-40% at a rate of 2 L/min to maintain end-tidal carbon dioxide of 35-40 mm Hg. Reversal of neuromuscular blockade will be achieved by intravenous administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the population of the study will be randomly selected from the daily scheduled cases undergoing ERCP in the Gastroenterology department of Theodor Bilhrarz research institute.
Key inclusion criteria (3 listed)
- ASA 1-3.
- Age above 18 years old.
- Preoperative pulmonary stability criteria (defined as a respiratory rate 12-24 breaths per minute, SpO2 ≥ 94% on room air) -
Key exclusion criteria (11 listed)
- Age < 18 years.
- Morbid obesity BMI ≥ 40 Kg/ m2.
- Pregnancy.
- Fasting ≤ 6 hours for solid food and ≤ 2 hours for clear liquids. 4
- A pre-existing lung condition in patients requiring supplemental oxygen, inhalational bronchodilator, or systemic bronchodilator or steroid.
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 |
|---|---|---|
| Imagingpre and postoperative CT scan of lung | Radiation | Genral anesthesia, deep sedation |
Primary outcome
POPA
Time frame: 24 hours postoperatively
Perioperative Pulmonary Aspiration (POPA), which will be defined as the presence of an acute pulmonary infiltrate on chest CT within the 24 hours period following ERCP.
1 secondary outcome
Number of intraoperative hypoxic episodes.
Time frame: 24 hours postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 11778129Shah SK, Mutignani M, Costamagna G. Therapeutic biliary endoscopy. Endoscopy. 2002 Jan;34(1):43-53. doi: 10.1055/s-2002-19395.
- Background: PubMed 27708522Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol. 2016 Oct-Dec;29(4):530-535. doi: 10.20524/aog.2016.0071. Epub 2016 Jul 14.
- Background: PubMed 23635608Garewal D, Vele L, Waikar P. Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures. Curr Opin Anaesthesiol. 2013 Aug;26(4):475-80. doi: 10.1097/ACO.0b013e3283620139.
- Background: PubMed 21295639Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.
- Background: PubMed 24202650Sorser SA, Fan DS, Tommolino EE, Gamara RM, Cox K, Chortkoff B, Adler DG. Complications of ERCP in patients undergoing general anesthesia versus MAC. Dig Dis Sci. 2014 Mar;59(3):696-7. doi: 10.1007/s10620-013-2932-2. Epub 2013 Nov 8. No abstract available.
- Background: PubMed 23877477Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Pulmonary Microaspiration, run by Theodor Bilharz Research Institute 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 3 inclusion and 11 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 8 Apr 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 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?
Results are not available in the source record.
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?
POPA (time frame: 24 hours postoperatively). 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 NCT04831489, which also lists 6 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 8 Apr 2021.