Mechanical Ventilation ComplicationNCT03526003
Effect of Position and Pneumoperitoneum on Respiratory Mechanics and Transpulmonary Pressure During Laparoscopic Surgery
An observational study of Mechanical Ventilation Complication, run by Rambam Health Care Campus.
Trial summary
This study is an observational study measuring the esophageal pressure in anesthetized surgical patient undergoing changes in posture and pneumoperitoneum Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Measurement of esophageal pressure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2018to 15 May 2020
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for elective laparoscopic surgery aged between 20 and 80 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 25 or higher than 45 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.
Who may be able to join
- patients scheduled for laparoscopic surgery
- body mass index between 25 and 45
Who cannot join
- pregnancy
- contraindications for insertion of nasogastric tube
Trial locations and contacts
No sites are listed yet.
About this study
This study is an observational study measuring the esophageal pressure in anesthetized surgical patient undergoing changes in posture and pneumoperitoneum
Read the detailed description
The study is a prospective observational study. Following approval by the Institutional Review Board, the study will be performed in a prospective, longitudinal cohort manner. Patients scheduled for elective laparoscopic surgery aged between 20 and 60 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 18 or higher than 40 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.
Following induction of anesthesia using fentanyl 2-5 microgram/kg, propofol 1-3 mg/kg and muscle relaxation with rocuronium 0.6-0.8 mg/kg, the trachea will be intubated using a 7-8 mm ID endotracheal tube. Mechanical ventilation in a volume controlled mode with a tidal volume 6-8 ml/kg and a PEEP of 5 cm of water will be initiated at a rate of 12-16 breaths per minute using an anesthesia machine (Fabius GS Premium, Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Balanced general anesthesia will be maintained by sevoflurane and fentanyl.
Esophageal balloon catheter will be placed according to manufacturer instructions 9. In brief, the stomach will be decompressed and suctioned with an 18 F orogastric tube. This tube will be also utilized to estimate the depth of the lower esophageal sphincter, a measure that will be corroborated with external simulation of the approximate distance from the gastric opening to the nares. A lubricated 86 cm long closed-tip catheter with a 9.5 cm long balloon catheter at its distal end will be gently inserted via one nostril and advanced into the esophagus. The calculated depth aiding in positioning the balloon at the lower third of the thoracic cavity at about 10 cm above the lower esophageal sphincter, as guided by catheter markings, will be the product of patient height x 0.288. This location had been verified by the external measurements at described above. An extension tubing will be attached to the Y piece at the proximal ending of the catheter and connected to a syringe and a pre-calibrated pressure transducer via a 3-way stopcock. One ml of air will be injected into the balloon so that it became semi inflated, and the tracing on the pressure monitor will be adjusted with additional small amounts of air until no flattening or damping will be noted in the pressure waveform. When properly positioned, the catheter will be secured with tape to prevent movement or extubation.
Esophageal pressure will be continuously measured via a calibrated pressure transducer system (Art-Line ,BioMetrix, Kiryat Mada, Jerusalem, Israel) connected to a patient monitor (Datex AS/3, Datex Ohmeda Medical Equipment, GE Healthcare, USA) and recorded using a designated computer software.
Esophageal pressure will be documented with the patient at horizontal position, and with the head up, operating table elevated 20 cm (anti Trendelenburg position) and head down, operating table lowill bed 20 cm (Trendelenburg position).
Following peritoneal access and trocar insertion, the peritoneal cavity will be gradually inflated with carbon dioxide by a laparoscopy insufflator (UHI-4 High Flow Insufflation Unit, Olympus Corporation Inc., Center Valley, PA, USA) and esophageal pressure will be recorded at a stable peritoneal pressure of 5, 10 and 15 mmHg. Following complete peritoneal inflation, the esophageal balloon catheter will be removed and recording terminated.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Measurement of esophageal pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of esophageal pressureDiagnostic test
Measurement of esophageal pressure during posture changes and pneumoperotoneum
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Adult patient scheduled for laparoscopic surgery under general anesthesia Receives: Diagnostic Test: Measurement of esophageal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in esophageal pressure
Effect of posture and pneumoperitoneum on esophageal pressure
Measured: From immidiatly after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start15 Jul 2018 (estimated)
- Primary completion15 May 2019 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526003
- Sponsor's protocol ID
- 075-18
- Status last verified
- Jun 2018
- First submitted
- 3 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: will not make ipd available
Publications
Fish E, Novack V, Banner-Goodspeed VM, Sarge T, Loring S, Talmor D. The Esophageal Pressure-Guided Ventilation 2 (EPVent2) trial protocol: a multicentre, randomised clinical trial of mechanical ventilation guided by transpulmonary pressure. BMJ Open. 2014 Oct 6;4(9):e006356. doi: 10.1136/bmjopen-2014-006356.
PubMed 25287106Plataki M, Hubmayr RD. Should mechanical ventilation be guided by esophageal pressure measurements? Curr Opin Crit Care. 2011 Jun;17(3):275-80. doi: 10.1097/MCC.0b013e328344dda6.
PubMed 21326094
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Position and Pneumoperitoneum on Respiratory Mechanics and Transpulmonary Pressure During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03526003
- Acronym / sponsor ID
- 075-18
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Jul 2018 (estimated)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 16 May 2018 (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.
This study is an observational study measuring the esophageal pressure in anesthetized surgical patient undergoing changes in posture and pneumoperitoneum
Detailed description
The study is a prospective observational study. Following approval by the Institutional Review Board, the study will be performed in a prospective, longitudinal cohort manner. Patients scheduled for elective laparoscopic surgery aged between 20 and 60 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 18 or higher than 40 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.
Following induction of anesthesia using fentanyl 2-5 microgram/kg, propofol 1-3 mg/kg and muscle relaxation with rocuronium 0.6-0.8 mg/kg, the trachea will be intubated using a 7-8 mm ID endotracheal tube. Mechanical ventilation in a volume controlled mode with a tidal volume 6-8 ml/kg and a PEEP of 5 cm of water will be initiated at a rate of 12-16 breaths per minute using an anesthesia machine (Fabius GS Premium, Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Balanced general anesthesia will be maintained by sevoflurane and fentanyl.
Esophageal balloon catheter will be placed according to manufacturer instructions 9. In brief, the stomach will be decompressed and suctioned with an 18 F orogastric tube. This tube will be also utilized to estimate the depth of the lower esophageal sphincter, a measure that will be corroborated with external simulation of the approximate distance from the gastric opening to the nares. A lubricated 86 cm long closed-tip catheter with a 9.5 cm long balloon catheter at its distal end will be gently inserted via one nostril and advanced into the esophagus. The calculated depth aiding in positioning the balloon at the lower third of the thoracic cavity at about 10 cm above the lower esophageal sphincter, as guided by catheter markings, will be the product of patient height x 0.288. This location had been verified by the external measurements at described above. An extension tubing will be attached to the Y piece at the proximal ending of the catheter and connected to a syringe and a pre-calibrated pressure transducer via a 3-way stopcock. One ml of air will be injected into the balloon so that it became semi inflated, and the tracing on the pressure monitor will be adjusted with additional small amounts of air until no flattening or damping will be noted in the pressure waveform. When properly positioned, the catheter will be secured with tape to prevent movement or extubation.
Esophageal pressure will be continuously measured via a calibrated pressure transducer system (Art-Line ,BioMetrix, Kiryat Mada, Jerusalem, Israel) connected to a patient monitor (Datex AS/3, Datex Ohmeda Medical Equipment, GE Healthcare, USA) and recorded using a designated computer software.
Esophageal pressure will be documented with the patient at horizontal position, and with the head up, operating table elevated 20 cm (anti Trendelenburg position) and head down, operating table lowill bed 20 cm (Trendelenburg position).
Following peritoneal access and trocar insertion, the peritoneal cavity will be gradually inflated with carbon dioxide by a laparoscopy insufflator (UHI-4 High Flow Insufflation Unit, Olympus Corporation Inc., Center Valley, PA, USA) and esophageal pressure will be recorded at a stable peritoneal pressure of 5, 10 and 15 mmHg. Following complete peritoneal inflation, the esophageal balloon catheter will be removed and recording terminated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Diagnostic Test: Measurement of esophageal pressureAdult patient scheduled for laparoscopic surgery under general anesthesia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective laparoscopic surgery aged between 20 and 80 years will be included. Each participant signed an informed consent. Exclusion criteria included respiratory pathology, a body mass index lower than 25 or higher than 45 kg/m2, esophageal pathology and previous esophageal or pulmonary operation.
Key inclusion criteria (2 listed)
- patients scheduled for laparoscopic surgery
- body mass index between 25 and 45
Key exclusion criteria (2 listed)
- pregnancy
- contraindications for insertion of nasogastric tube
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 |
|---|---|---|
| Measurement of esophageal pressureMeasurement of esophageal pressure during posture changes and pneumoperotoneum | Diagnostic test | Surgical patients |
Primary outcome
Changes in esophageal pressure
Time frame: From immidiatly after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumoperitoneum
Effect of posture and pneumoperitoneum on esophageal pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 25287106Fish E, Novack V, Banner-Goodspeed VM, Sarge T, Loring S, Talmor D. The Esophageal Pressure-Guided Ventilation 2 (EPVent2) trial protocol: a multicentre, randomised clinical trial of mechanical ventilation guided by transpulmonary pressure. BMJ Open. 2014 Oct 6;4(9):e006356. doi: 10.1136/bmjopen-2014-006356.
- Background: PubMed 21326094Plataki M, Hubmayr RD. Should mechanical ventilation be guided by esophageal pressure measurements? Curr Opin Crit Care. 2011 Jun;17(3):275-80. doi: 10.1097/MCC.0b013e328344dda6.
- Individual participant dataSharing planned: No. will not make ipd available
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by Rambam Health Care Campus.
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 2 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Amit Lehavi, MD (972-50-20161419, amit.lehavi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in esophageal pressure (time frame: From immidiatly after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumoperitoneum). 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 NCT03526003, which also lists 2 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 6 Jun 2018.