Ventilator LungNCT03411239
Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Laparoscopic Surgery
A study testing Adult esophageal balloon catheter (obc) in people with Ventilator Lung, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a single centre study. The investigators intend to recruit 20 subjects over 4 months. Patients undergoing laparoscopic abdominal surgery for cholecystectomy, laparoscopic gynaecological surgery and laparoscopic urologic procedures either as day surgery, same day admission or in patients, will be included in… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- Adult esophageal balloon catheter (obc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Mar 2018to 30 Sep 2022
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade 1 and 2 patients,
- Age > 21 yrs.
- Elective intraabdominal laparoscopic surgery
Who cannot join
- ASA grade 3 and 4 patients
- Emergency surgery
- Patient with tracheostomy
- Patient with any oropharyngeal pathology
- Patients with co-existing respiratory disease i.e. COPD, restrictive lung disease.
- Patients with oesophageal diseases: varicose, stricture, recent esophageal or gastric surgery.
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- Patients with nasopharyngeal diseases: sinusitis, epistaxis, nasopharyngeal carcinoma post radiotherapy or chemotherapy.
- Age < 21 years
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Patients Undergoing Laparoscopic Surgery Under General Anaesthesia
This is a single centre study. The investigators intend to recruit 20 subjects over 4 months. Patients undergoing laparoscopic abdominal surgery for cholecystectomy, laparoscopic gynaecological surgery and laparoscopic urologic procedures either as day surgery, same day admission or in patients, will be included in the study. Patients will be identified at the time of listing for surgery and referred to study team, which in turn will recruit the patients. Informed consent will be obtained at the time of recruitment and a copy of consent with details of principal investigator would be provided to subjects. All data collection will be done intraoperative. Patient would be followed up once at day 3 post op period. If patients have any complications related to the study, they will be followed up weekly until the complication is resolved.
Read the detailed description
General anaesthesia: Patients will be induced and intubated as per the choice of consultant anaesthetist. Anaesthesia will be maintained with inhalational agent and paralysis maintained with atracurium infusion or bolus so as to keep train of four counts <2 twitches using peripheral nerve stimulator throughout surgery. Conventional ventilation was standardised with mode as pressure control ventilation, pressure inspired targeted to either tidal ventilation of 6-8 ml/kg or end tidal carbon di oxide concentration of 40-50 mmHg and positive end expiratory pressure limited to 5 cm of water. Fraction of inspiratory oxygen was adjusted to keep oxygen saturation > 95%. No recruitment manoeuvres were permitted unless, patient is desaturating actively, and in which case patient will be excluded from the study. Abdominal cavity was insufflated with carbon dioxide with initial high flow and pressure, but later the pressure was maintained at 15cm water.
Esophageal balloon catheter insertion, placement and removal: After applying topical anaesthetic (10% lidocaine spray) to patient's nasopharynx and water-soluble lubricant jelly to distal end of esophageal catheter, it is inserted into patient's esophagus via nasal cavity or oropharyngeal cavity. Estimated depth of catheter insertion is calculated as: patient's height (in cm) X 0.288. Once the esophageal balloon catheter is inserted to estimated depth, balloon is inflated with 4 ml of air and pressure on the stomach is applied to look for positive deflection of oesophageal pressure reading. Once convinced, 2 ml air was taken out and catheter was slowly withdrawn till cardiac oscillations are visible. Occlusion test is performed to confirm the placement of catheter in lower thoracic region. In occlusion test, patient is briefly disconnected from ventilator, endotracheal tube is blocked and pressure is applied on to chest wall. Simultaneous increase in oesophageal balloon pressure and airway pressure is noted. (Change is oesophageal pressure/ change in airway pressure on application of external pressure should be close to 1). Stylet is removed and Oesophageal balloon catheter is secured at this position on nostril or angle of mouth similar to nasogastric tube and connected to pressure transducer to do necessary measurements. Catheter is removed at the end of surgery before extubation after complete deflation of cuff.
Measurements: Soon after confirmation of position, patient is subjected to end inspiratory hold to record the end inspiratory pleural pressure and plateau airway pressure. Patient is then subjected to end expiratory hold to record end expiratory pleural pressure and positive end expiratory pressure. Similar steps are repeated once pneumoperitoneum is achieved and patient is placed in trendelenburg or reverse trendelenburg position and once pneumoperitoneum deflated. Problems encountered during insertion and measurement of esophageal balloon catheter will be resolved using manufacturer's recommendation.
- Conditions
- Ventilator Lung
- Being tested
- Adult esophageal balloon catheter (obc)
- Keywords
- Airway pressure, Oesophageal pressure, transpulmonary pressure, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult esophageal balloon catheter (obc)Device
Using OBC to determine airway pressure changes in patients undergoing general anaesthesia for laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Other | Patients recruited will have OBC inserted under general anaesthesia and various pressure measured Receives: Device: Adult esophageal balloon catheter (obc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory and expiratory oesophageal pressure during laparoscopic surgery
using pressure monitoring line
Measured: 1 year
Inspiratory and expiratory transpulmonary pressure during laparoscopic surgery
difference between oesophageal pressure and airway pressures
Measured: 1 year
Inspiratory and expiratory transpulmonary pressure during supine, trendelenburg and reverse trendelenburg position
difference between esophageal pressure and airway pressure in various positions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start8 Mar 2018
- Primary completion30 Apr 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rohit V Agrawal, MMed, FANZCA, Principal investigator, Consultant, Department of Anaesthesia, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411239
- Sponsor's protocol ID
- 2017/00153
- Other IDs
- 2017
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2017
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, results, analysis
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Patients Undergoing Laparoscopic Surgery Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT03411239
- Acronym / sponsor ID
- 2017/00153
- Conditions
- Ventilator Lung
- Keywords
- Airway pressure, Oesophageal pressure, transpulmonary pressure, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Jan 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 is a single centre study. The investigators intend to recruit 20 subjects over 4 months. Patients undergoing laparoscopic abdominal surgery for cholecystectomy, laparoscopic gynaecological surgery and laparoscopic urologic procedures either as day surgery, same day admission or in patients, will be included in the study. Patients will be identified at the time of listing for surgery and referred to study team, which in turn will recruit the patients. Informed consent will be obtained at the time of recruitment and a copy of consent with details of principal investigator would be provided to subjects. All data collection will be done intraoperative. Patient would be followed up once at day 3 post op period. If patients have any complications related to the study, they will be followed up weekly until the complication is resolved.
Detailed description
General anaesthesia: Patients will be induced and intubated as per the choice of consultant anaesthetist. Anaesthesia will be maintained with inhalational agent and paralysis maintained with atracurium infusion or bolus so as to keep train of four counts <2 twitches using peripheral nerve stimulator throughout surgery. Conventional ventilation was standardised with mode as pressure control ventilation, pressure inspired targeted to either tidal ventilation of 6-8 ml/kg or end tidal carbon di oxide concentration of 40-50 mmHg and positive end expiratory pressure limited to 5 cm of water. Fraction of inspiratory oxygen was adjusted to keep oxygen saturation > 95%. No recruitment manoeuvres were permitted unless, patient is desaturating actively, and in which case patient will be excluded from the study. Abdominal cavity was insufflated with carbon dioxide with initial high flow and pressure, but later the pressure was maintained at 15cm water.
Esophageal balloon catheter insertion, placement and removal: After applying topical anaesthetic (10% lidocaine spray) to patient's nasopharynx and water-soluble lubricant jelly to distal end of esophageal catheter, it is inserted into patient's esophagus via nasal cavity or oropharyngeal cavity. Estimated depth of catheter insertion is calculated as: patient's height (in cm) X 0.288. Once the esophageal balloon catheter is inserted to estimated depth, balloon is inflated with 4 ml of air and pressure on the stomach is applied to look for positive deflection of oesophageal pressure reading. Once convinced, 2 ml air was taken out and catheter was slowly withdrawn till cardiac oscillations are visible. Occlusion test is performed to confirm the placement of catheter in lower thoracic region. In occlusion test, patient is briefly disconnected from ventilator, endotracheal tube is blocked and pressure is applied on to chest wall. Simultaneous increase in oesophageal balloon pressure and airway pressure is noted. (Change is oesophageal pressure/ change in airway pressure on application of external pressure should be close to 1). Stylet is removed and Oesophageal balloon catheter is secured at this position on nostril or angle of mouth similar to nasogastric tube and connected to pressure transducer to do necessary measurements. Catheter is removed at the end of surgery before extubation after complete deflation of cuff.
Measurements: Soon after confirmation of position, patient is subjected to end inspiratory hold to record the end inspiratory pleural pressure and plateau airway pressure. Patient is then subjected to end expiratory hold to record end expiratory pleural pressure and positive end expiratory pressure. Similar steps are repeated once pneumoperitoneum is achieved and patient is placed in trendelenburg or reverse trendelenburg position and once pneumoperitoneum deflated. Problems encountered during insertion and measurement of esophageal balloon catheter will be resolved using manufacturer's recommendation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Other | Device: Adult esophageal balloon catheter (obc)Patients recruited will have OBC inserted under general anaesthesia and various pressure measured |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA grade 1 and 2 patients,
- Age > 21 yrs.
- Elective intraabdominal laparoscopic surgery
Key exclusion criteria (9 listed)
- ASA grade 3 and 4 patients
- Emergency surgery
- Patient with tracheostomy
- Patient with any oropharyngeal pathology
- Patients with co-existing respiratory disease i.e. COPD, restrictive lung disease.
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 |
|---|---|---|
| Adult esophageal balloon catheter (obc)Using OBC to determine airway pressure changes in patients undergoing general anaesthesia for laparoscopic surgery | Device | Interventional arm |
Primary outcome
Inspiratory and expiratory oesophageal pressure during laparoscopic surgery
Time frame: 1 year
using pressure monitoring line
Inspiratory and expiratory transpulmonary pressure during laparoscopic surgery
Time frame: 1 year
difference between oesophageal pressure and airway pressures
Inspiratory and expiratory transpulmonary pressure during supine, trendelenburg and reverse trendelenburg position
Time frame: 1 year
difference between esophageal pressure and airway pressure in various positions
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 27 Jul 2023.
- Individual participant dataSharing planned: Undecided. Study protocol, results, analysis
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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.
Rohit V Agrawal, MMed, FANZCA principal investigator
Consultant, Department of Anaesthesia, NUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult esophageal balloon catheter (obc) in people with Ventilator Lung, run by National University Hospital, Singapore at 1 site in Singapore.
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 9 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 27 Jul 2023. 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 Singapore. 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?
Inspiratory and expiratory oesophageal pressure during laparoscopic surgery (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.