AzTrials
AzTrials

AnesthesiaInprove4largeNCT03157479

Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

A study testing Intravenous anesthetic, Crystalloid Solutions and Esophageal pressure measurement in people with Anesthesia and Surgery--Complications, run by Catholic University of the Sacred Heart at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anesthesia, Surgery--Complications
What is being tested?
Intravenous anesthetic, Crystalloid Solutions and Esophageal pressure measurement
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
1 May 2017to 31 Mar 2019
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
  • Obesity with body mass index>35 kg/m^2
  • written informed consent

Who cannot join

  • Clinical history or signs of chronic heart failure
  • history of neuromuscular disease
  • history of thoracic surgery
  • pregnancy
  • chronic respiratory failure requiring long-term oxygen administration

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • General surgery OR, A. Gemelli hospital

    Rome, 00100

Other trials in Italy

About this study

Official title: Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial

Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.

Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.

Being tested
Intravenous anesthetic, Crystalloid Solutions, Esophageal pressure measurement, Lung volume measurement with the nitrogen washin-washout technique
Keywords
Mechanical ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous anestheticDrug

    Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50

  • Crystalloid SolutionsDrug

    Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician

  • Esophageal pressure measurementDiagnostic test

    A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure

  • Lung volume measurement with the nitrogen washin-washout techniqueDiagnostic test

    Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.

Study groups in NCT03157479
Study groupRoleWhat they receive
Protective ventilationExperimentalVolume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height [cm] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached.
Receives: Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique
Standard VentilationActive comparatorVolume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height [cm] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second
Receives: Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative oxygenation

    PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%

    Measured: One hour after extubation

Secondary outcomes (14)

  1. Postoperative forced expiratory volume in 1 second (FEV1)

    volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity

    Measured: 48 hours after the end of surgery

  2. Postoperative forced vital capacity (FVC)

    the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity

    Measured: 48 hours after the end of surgery

  3. Postoperative Tiffeneau index

    computed as FEV1/FVC

    Measured: 48 hours after the end of surgery

  4. Postoperative Dyspnea

    Dyspnea assessed by Borg dyspnea scale

    Measured: 1 hour after surgery

  5. Pulmonary infection

    modified clinical pulmonary infection score (mCPIS)

    Measured: 24 hours after the end of surgery

  6. Postoperative pulmonary infiltrates

    Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment

    Measured: 24 hours after the end of surgery

  7. Intraoperative driving pressure

    driving pressure, computed as Plateau pressure-PEEP

    Measured: during surgery, recorded on a 60-minute basis

  8. Intraoperative lung driving pressure

    transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure

    Measured: during surgery, recorded on a 60-minute basis

  9. Intraoperative oxygenation

    PaO2/FiO2

    Measured: during surgery, recorded on a 60-minute basis

  10. Intraoperative dead space

    Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2

    Measured: during surgery, recorded on a 60-minute basis

  11. Lung recruitment

    lung recruitment/changes in end expiratory lung volume between the two groups

    Measured: during surgery, recorded on a 60-minute basis

  12. Intraoperative blood pressure

    Arterial blood pressure

    Measured: during surgery, recorded on a 60-minute basis

  13. Intraoperative respiratory system compliance

    computed as Tidal volume/airway driving pressure

    Measured: during surgery, recorded on a 60-minute basis

  14. Intraoperative lung compliance

    computed as Tidal volume/lung driving pressure

    Measured: during surgery, recorded on a 60-minute basis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start1 May 2017
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157479
Sponsor's protocol ID
InproveForLarge
Acronym
Inprove4large
Status last verified
May 2019
First submitted
12 May 2017
Last updated
20 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Grieco DL, Russo A, Anzellotti GM, Romano B, Bongiovanni F, Dell'Anna AM, Mauti L, Cascarano L, Gallotta V, Rosa T, Varone F, Menga LS, Polidori L, D'Indinosante M, Cappuccio S, Galletta C, Tortorella L, Costantini B, Gueli Alletti S, Sollazzi L, Scambia G, Antonelli M. Lung-protective ventilation during Trendelenburg pneumoperitoneum surgery: A randomized clinical trial. J Clin Anesth. 2023 May;85:111037. doi: 10.1016/j.jclinane.2022.111037. Epub 2022 Dec 7.

    PubMed 36495775

Questions about this trial

What is this clinical trial studying?

A study testing Intravenous anesthetic, Crystalloid Solutions and Esophageal pressure measurement in people with Anesthesia and Surgery--Complications, run by Catholic University of the Sacred Heart at 1 site in Italy.

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 5 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 20 May 2019. 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 Italy. 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?

Postoperative oxygenation (time frame: One hour after extubation). 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 NCT03157479, 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 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in