Lung Injury, AcuteNCT03637530
a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries
A study testing inverse ratio ventilation in people with Lung Injury, Acute, run by All India Institute of Medical Sciences, Rishikesh.
Trial summary
Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lung Injury, Acute
- What is being tested?
- inverse ratio ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Oct 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- ASA- I and II
- Patients undergoing laparoscopic upper abdominal surgery
Who cannot join
- Significant pulmonary disease
- Significant cardiac dysfunction
- BMI>30 kg/m2
About this study
Official title: A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery
Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. In turn it will be associated with increase in peak and plateau airway pressure during positive pressure ventilation. Inverse ratio ventilation has been shown to improve lung compliance and restrict the peak and plateau airway pressure and should be useful as one of the lung protective ventilation method to improve respiratory outcome in laparoscopy surgery.
Read the detailed description
Anaesthesiologists have been ventilating patients in the perioperative period with relatively large tidal volumes (10-15 ml/kg ideal body weight) to prevent intraoperative atelectasis. Ventilating patient with large tidal volumes may be a risk factor for development of lung injury.During surgical procedures, both general anesthesia and high tidal volumes may strain non injured lungs and trigger inflammation. High tidal volumes that cause alveolar overstretching can contribute to extra pulmonary organ dysfunction through systemic release of inflammatory mediators.
Recently protective lung ventilation strategies has been reported to be useful to reduce the respiratory complications in postoperative period. The use of small tidal volume (Vt), positive end-expiratory pressure (PEEP) and restricting peak airway pressure have shown reduced incidence of ventilation induced lung injury.
It has been shown that a small tidal volume (VT) and PEEP can reduce the incidence of postoperative lung dysfunction and improve intraoperative oxygenation. Restricting peak airway pressure can be achieved by inverse ratio ventilation. Minimizing the risk of ventilator-induced lung injury (VILI), improving oxygenation and alveolar recruitment are all advantages of inverse ratio ventilation. However, the potential utility of pressure controlled inverse ratio ventilation (PCIRV) has not been studied in patients undergoing general anaesthesia.
Investigators hypothesized that in patients with normal lungs scheduled for general anesthesia, PIV might prevent lung function deterioration and lung morphological alterations. Investiagators aim was to compare the intraoperative protective ventilation strategies on oxygenation/ ventilation and postoperative lung dysfunction and lung injury among patients undergoing laparoscopic upper abdominal surgery.
- Conditions
- Lung Injury, Acute
- Being tested
- inverse ratio ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverse ratio ventilationOther
during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | in this group of patients, inverse ratio ventilation is provided during general anaesthesia Receives: Other: inverse ratio ventilation |
| control group | No intervention | in this group of patients, conventional ventilation is provided during general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in partial pressure of oxygen from baseline
Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures
Measured: upto 1 day postoperatively
Secondary outcomes (1)
changes in pulmonary function tests from baseline
Investigators assume that the pulmonary function tests will be improved as we ventilate with inverse ratio ventilation as a protective lung strategy
Measured: upto 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startDec 2016
- Primary completionMay 2018
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Injury, AcuteStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Rishikesh
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences, Rishikesh
- Investigators
- MUKESH TRIPATHI, MD, Study director, PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637530
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I would like to share the results of my trail once it gets completed so that the effectiveness of the intervention will be known to others
Publications
8. Wang, X.Q., Wang, P.M., Wang, K.G., Jiang, T. and Xu, Z. Pressure-Controlled Inverse Ratio Ventilation during General Anesthesia for Open Abdominal Surgery Improves Postoperative Pulmonary Function. J. Biomedical Science and Engineering, 9, 17-24
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03637530
- Conditions
- Lung Injury, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, RishikeshOther government
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Aug 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.
Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. In turn it will be associated with increase in peak and plateau airway pressure during positive pressure ventilation. Inverse ratio ventilation has been shown to improve lung compliance and restrict the peak and plateau airway pressure and should be useful as one of the lung protective ventilation method to improve respiratory outcome in laparoscopy surgery.
Detailed description
Anaesthesiologists have been ventilating patients in the perioperative period with relatively large tidal volumes (10-15 ml/kg ideal body weight) to prevent intraoperative atelectasis. Ventilating patient with large tidal volumes may be a risk factor for development of lung injury.During surgical procedures, both general anesthesia and high tidal volumes may strain non injured lungs and trigger inflammation. High tidal volumes that cause alveolar overstretching can contribute to extra pulmonary organ dysfunction through systemic release of inflammatory mediators.
Recently protective lung ventilation strategies has been reported to be useful to reduce the respiratory complications in postoperative period. The use of small tidal volume (Vt), positive end-expiratory pressure (PEEP) and restricting peak airway pressure have shown reduced incidence of ventilation induced lung injury.
It has been shown that a small tidal volume (VT) and PEEP can reduce the incidence of postoperative lung dysfunction and improve intraoperative oxygenation. Restricting peak airway pressure can be achieved by inverse ratio ventilation. Minimizing the risk of ventilator-induced lung injury (VILI), improving oxygenation and alveolar recruitment are all advantages of inverse ratio ventilation. However, the potential utility of pressure controlled inverse ratio ventilation (PCIRV) has not been studied in patients undergoing general anaesthesia.
Investigators hypothesized that in patients with normal lungs scheduled for general anesthesia, PIV might prevent lung function deterioration and lung morphological alterations. Investiagators aim was to compare the intraoperative protective ventilation strategies on oxygenation/ ventilation and postoperative lung dysfunction and lung injury among patients undergoing laparoscopic upper abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: inverse ratio ventilationin this group of patients, inverse ratio ventilation is provided during general anaesthesia |
| control group | No intervention | –in this group of patients, conventional ventilation is provided during general anaesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- ASA- I and II
- Patients undergoing laparoscopic upper abdominal surgery
Key exclusion criteria (3 listed)
- Significant pulmonary disease
- Significant cardiac dysfunction
- BMI>30 kg/m2
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 |
|---|---|---|
| inverse ratio ventilationduring general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics | Other | intervention group |
Primary outcome
change in partial pressure of oxygen from baseline
Time frame: upto 1 day postoperatively
Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures
1 secondary outcome
changes in pulmonary function tests from baseline
Time frame: upto 3 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Background8. Wang, X.Q., Wang, P.M., Wang, K.G., Jiang, T. and Xu, Z. Pressure-Controlled Inverse Ratio Ventilation during General Anesthesia for Open Abdominal Surgery Improves Postoperative Pulmonary Function. J. Biomedical Science and Engineering, 9, 17-24
- Individual participant dataSharing planned: Undecided. I would like to share the results of my trail once it gets completed so that the effectiveness of the intervention will be known to others
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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.
MUKESH TRIPATHI, MD study director
PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH
Questions about this trial
What is this clinical trial studying?
A study testing inverse ratio ventilation in people with Lung Injury, Acute, run by All India Institute of Medical Sciences, Rishikesh.
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 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: status not confirmed, as of the sponsor's last update on 20 Aug 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?
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?
change in partial pressure of oxygen from baseline (time frame: upto 1 day 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 NCT03637530, which also lists 1 linked publication.
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 20 Aug 2018.