Eosinophilic EsophagitisNCT02038894
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
A study testing Intubated with Sevoflurane (IS), Intubated with Propofol (IP) and Zofran - no intubation in people with Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Intubated with Sevoflurane (IS), Intubated with Propofol (IP) and Zofran - no intubation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD
- Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia
- Patient must be between ages 1 and 12 years (inclusive)
- Patient must be American Society of Anesthesiology (ASA) class I or II;
- Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only
- Patient must have fasted according to CCHMC policy
- Patient's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate
Who cannot join
- Patients less than a year old and greater than 12 years old
- Patients undergoing therapeutic upper endoscopy
- Patients with an ASA physical status III or greater (other than EE patients)
- Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)
- Patients with personal or family history of malignant hyperthermia
- Obese patients (Body mass index more than 95th percentile for age)
Show all 13Show fewer
- Patients with significant airway abnormalities (e.g., trisomy 21, craniofacial syndromes, sub-glottic stenosis, tracheomalacia, tracheostomy)
- Patients with history of obstructive sleep apnea
- Patient receiving sedative premedication
- Patient previously treated under this protocol
- Patients with symptoms of an active upper respiratory infection
- Patients with history of coagulopathy
- Patients with esophageal varices or gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.
Read the detailed description
Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC) for delivering anesthesia during an esophagogastroduodenoscopy (EGD). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience. One anesthetic technique involves the use of general anesthesia with the placement of an endotracheal tube, and maintenance with an inhalation agent, such as sevoflurane (IS). These patients may be extubated under deep anesthesia in the operating room, and allowed to awaken in the post anesthesia care unit. A similar technique involves the placement of an endotracheal tube, and anesthetic maintenance with a continuous infusion of propofol (IP). These patients are also extubated under deep anesthesia in the operating room, and allowed to awaken in the postoperative care unit. The third technique does not use an endotracheal tube and anesthetic maintenance occurs with continuous infusion of propofol with the patient breathing oxygen through their natural airway (NA). Our objective in this study is to compare outcomes between these three established anesthetic techniques.
Children in the study will be recruited from Cincinnati Children's Hospital Medical Center Operating Room Schedule. They will be cared for in the Operating Rooms and Post Anesthesia Care Unit.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Intubated with Sevoflurane (IS), Intubated with Propofol (IP), Zofran - no intubation, Propofol
- Keywords
- Anesthetic, Pediatric, Esophagogastroduodenoscopies, Eosinophilic esophagitis, Gastroesophageal reflux disease (GERD), Abdominal Pain, Vomiting, Sevofluorane, Propofol, Nasal cannula, Intubation, Endotracheal tube
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Abdominal Pain, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubated with Sevoflurane (IS)Drug
Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.
Intubated with Propofol (IP)Drug
Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.
Zofran - no intubationDrug
A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Intubated with Sevoflurane (IS) | Active comparator | Anesthetic technique during (EGD) Receives: Drug: Intubated with Sevoflurane (IS) |
| Intubated with Propofol (IP) | Active comparator | Anesthetic technique during (EGD) Receives: Drug: Intubated with Propofol (IP) |
| Native Airway - no intubation | Active comparator | Anesthetic technique during (EGD) Receives: Drug: Zofran - no intubation; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Respiratory Complications
An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.
Measured: Admission for surgery through recovery period, approximately 3 hours
Secondary outcomes (1)
Peri-operative Times Between Three Different Anesthetic Techniques
Time measurements are used to evaluate the efficiency of the different techniques. We will compare the times spent in the operating room and the postoperative unit for each technique.
Measured: Admission for surgery through recovery period, approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startDec 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Patino, MD, Principal investigator, Cincinati Children's Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038894
- Sponsor's protocol ID
- 2009-0100
- Status last verified
- Sep 2020
- First submitted
- 1 May 2013
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hoffmann CO, Samuels PJ, Beckman E, Hein EA, Shackleford TM, Overbey E, Berlin RE, Wang Y, Nick TG, Gunter JB. Insufflation vs intubation during esophagogastroduodenoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):821-30. doi: 10.1111/j.1460-9592.2010.03357.x.
PubMed 20716074Brown RH, Wagner EM. Mechanisms of bronchoprotection by anesthetic induction agents: propofol versus ketamine. Anesthesiology. 1999 Mar;90(3):822-8. doi: 10.1097/00000542-199903000-00025.
PubMed 10078684Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.
PubMed 16306725Schwartz DA, Connelly NR, Theroux CA, Gibson CS, Ostrom DN, Dunn SM, Hirsch BZ, Angelides AG. Gastric contents in children presenting for upper endoscopy. Anesth Analg. 1998 Oct;87(4):757-60. doi: 10.1097/00000539-199810000-00003.
PubMed 9768765Lightdale JR, Mahoney LB, Schwarz SM, Liacouras CA. Methods of sedation in pediatric endoscopy: a survey of NASPGHAN members. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):500-2. doi: 10.1097/MPG.0b013e3180691168.
PubMed 18030225Elitsur Y, Blankenship P, Lawrence Z. Propofol sedation for endoscopic procedures in children. Endoscopy. 2000 Oct;32(10):788-91. doi: 10.1055/s-2000-7713.
PubMed 11068839Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B; Pediatric Sedation Research Consortium. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. doi: 10.1542/peds.2006-0313.
PubMed 16951002Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.
PubMed 17767636Thakkar K, El-Serag HB, Mattek N, Gilger MA. Complications of pediatric EGD: a 4-year experience in PEDS-CORI. Gastrointest Endosc. 2007 Feb;65(2):213-21. doi: 10.1016/j.gie.2006.03.015.
PubMed 17258979Kaddu R, Bhattacharya D, Metriyakool K, Thomas R, Tolia V. Propofol compared with general anesthesia for pediatric GI endoscopy: is propofol better? Gastrointest Endosc. 2002 Jan;55(1):27-32. doi: 10.1067/mge.2002.120386.
PubMed 11756910U.S Food and Drug Administration. Med Watch. The FDA Safety Information and AdverseReportingProgram.Availableat:http://www.fda.gov/medWatch/report/DESK/advevnt.htm
Patino M, Glynn S, Soberano M, Putnam P, Hossain MM, Hoffmann C, Samuels P, Kibelbek MJ, Gunter J. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial. Paediatr Anaesth. 2015 Oct;25(10):1013-9. doi: 10.1111/pan.12717. Epub 2015 Jul 17.
PubMed 26184697
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
- ClinicalTrials.gov ID
- NCT02038894
- Acronym / sponsor ID
- 2009-0100
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Anesthetic, Pediatric, Esophagogastroduodenoscopies, Eosinophilic esophagitis, Gastroesophageal reflux disease (GERD), Abdominal Pain, Vomiting, Sevofluorane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.
Detailed description
Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC) for delivering anesthesia during an esophagogastroduodenoscopy (EGD). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience. One anesthetic technique involves the use of general anesthesia with the placement of an endotracheal tube, and maintenance with an inhalation agent, such as sevoflurane (IS). These patients may be extubated under deep anesthesia in the operating room, and allowed to awaken in the post anesthesia care unit. A similar technique involves the placement of an endotracheal tube, and anesthetic maintenance with a continuous infusion of propofol (IP). These patients are also extubated under deep anesthesia in the operating room, and allowed to awaken in the postoperative care unit. The third technique does not use an endotracheal tube and anesthetic maintenance occurs with continuous infusion of propofol with the patient breathing oxygen through their natural airway (NA). Our objective in this study is to compare outcomes between these three established anesthetic techniques.
Children in the study will be recruited from Cincinnati Children's Hospital Medical Center Operating Room Schedule. They will be cared for in the Operating Rooms and Post Anesthesia Care Unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubated with Sevoflurane (IS) | Active comparator | Drug: Intubated with Sevoflurane (IS)Anesthetic technique during (EGD) |
| Intubated with Propofol (IP) | Active comparator | Drug: Intubated with Propofol (IP)Anesthetic technique during (EGD) |
| Native Airway - no intubation | Active comparator | Drug: Zofran - no intubation, Drug: PropofolAnesthetic technique during (EGD) |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD
- Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia
- Patient must be between ages 1 and 12 years (inclusive)
- Patient must be American Society of Anesthesiology (ASA) class I or II;
- Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only
Key exclusion criteria (13 listed)
- Patients less than a year old and greater than 12 years old
- Patients undergoing therapeutic upper endoscopy
- Patients with an ASA physical status III or greater (other than EE patients)
- Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)
- Patients with personal or family history of malignant hyperthermia
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 |
|---|---|---|
| Intubated with Sevoflurane (IS)Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia. | Drug | Intubated with Sevoflurane (IS) |
| Intubated with Propofol (IP)Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia. | Drug | Intubated with Propofol (IP) |
| Zofran - no intubationA nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. | Drug | Native Airway - no intubation |
| Propofol | Drug | Native Airway - no intubation |
Primary outcome
Number of Participants With Respiratory Complications
Time frame: Admission for surgery through recovery period, approximately 3 hours
An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.
1 secondary outcome
Peri-operative Times Between Three Different Anesthetic Techniques
Time frame: Admission for surgery through recovery period, approximately 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20716074Hoffmann CO, Samuels PJ, Beckman E, Hein EA, Shackleford TM, Overbey E, Berlin RE, Wang Y, Nick TG, Gunter JB. Insufflation vs intubation during esophagogastroduodenoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):821-30. doi: 10.1111/j.1460-9592.2010.03357.x.
- Background: PubMed 10078684Brown RH, Wagner EM. Mechanisms of bronchoprotection by anesthetic induction agents: propofol versus ketamine. Anesthesiology. 1999 Mar;90(3):822-8. doi: 10.1097/00000542-199903000-00025.
- Background: PubMed 16306725Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.
- Background: PubMed 9768765Schwartz DA, Connelly NR, Theroux CA, Gibson CS, Ostrom DN, Dunn SM, Hirsch BZ, Angelides AG. Gastric contents in children presenting for upper endoscopy. Anesth Analg. 1998 Oct;87(4):757-60. doi: 10.1097/00000539-199810000-00003.
- Background: PubMed 18030225Lightdale JR, Mahoney LB, Schwarz SM, Liacouras CA. Methods of sedation in pediatric endoscopy: a survey of NASPGHAN members. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):500-2. doi: 10.1097/MPG.0b013e3180691168.
- Background: PubMed 11068839Elitsur Y, Blankenship P, Lawrence Z. Propofol sedation for endoscopic procedures in children. Endoscopy. 2000 Oct;32(10):788-91. doi: 10.1055/s-2000-7713.
- Background: PubMed 16951002Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B; Pediatric Sedation Research Consortium. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. doi: 10.1542/peds.2006-0313.
- Background: PubMed 17767636Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.
- Background: PubMed 17258979Thakkar K, El-Serag HB, Mattek N, Gilger MA. Complications of pediatric EGD: a 4-year experience in PEDS-CORI. Gastrointest Endosc. 2007 Feb;65(2):213-21. doi: 10.1016/j.gie.2006.03.015.
- Background: PubMed 11756910Kaddu R, Bhattacharya D, Metriyakool K, Thomas R, Tolia V. Propofol compared with general anesthesia for pediatric GI endoscopy: is propofol better? Gastrointest Endosc. 2002 Jan;55(1):27-32. doi: 10.1067/mge.2002.120386.
- BackgroundU.S Food and Drug Administration. Med Watch. The FDA Safety Information and AdverseReportingProgram.Availableat:http://www.fda.gov/medWatch/report/DESK/advevnt.htm
- Results publication: PubMed 26184697Patino M, Glynn S, Soberano M, Putnam P, Hossain MM, Hoffmann C, Samuels P, Kibelbek MJ, Gunter J. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial. Paediatr Anaesth. 2015 Oct;25(10):1013-9. doi: 10.1111/pan.12717. Epub 2015 Jul 17.
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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.
Mario Patino, MD principal investigator
Cincinati Children's Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubated with Sevoflurane (IS), Intubated with Propofol (IP) and Zofran - no intubation in people with Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 7 inclusion and 13 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 24 Sep 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Respiratory Complications (time frame: Admission for surgery through recovery period, approximately 3 hours). 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 NCT02038894, which also lists 12 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 24 Sep 2020.