Peripheral Vascular DiseasesNCT04566016
General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Incidence of Postoperative Pulmonary Complications.
A study testing Regional anesthesia in people with Peripheral Vascular Diseases, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Regional anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2019to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ASA II to IV; age greater than 18 years; scheduled for arterial revascularization surgery on lower limbs.
Who cannot join
- Patients with a body mass index above 40 kg / m2 who underwent emergency surgery, with a history of pulmonary surgery, persistent hemodynamic instability in the preoperative period, history of asthma or chronic use of corticotherapy, or patients with history neuromuscular disorder. Patients with a history of use of anticoagulants or antiplatelet agents in the preoperative period who contraindicate the performance of spinal anesthesia will also be excluded from the study. In this study, only patients with peripheral vascular disease with critical and symptomatic ischemia in the lower limbs and scheduled to undergo elective arterial revascularization of the lower limbs will be included, and all patients with acute vascular obstruction or other associated vascular complications will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Effects on the Incidence of Postoperative Pulmonary Complications.
The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
Read the detailed description
In this prospective and randomized study, only adult ASA II to IV patients, aged over 18 years, scheduled to undergo lower limb arterial revascularization surgery at the Hospital de Clínicas in Porto Alegre and at the Hospital Nossa Senhora da Conceição will be included.
The study will be designed as a prospective clinical trial. Patients will be randomly allocated for treatment with spinal neuraxial anesthesia associated with spontaneous ventilation (nasal glasses with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume from 6 to 8 ml / kg of the assumed weight and PEEP of 5 cmH2O - Group 2).
Sampling will be carried out for convenience, including patients routinely seen in the operating room of the hospitals involved and who meet the inclusion and exclusion criteria of this study. The allocation of patients will be performed through a table of random numbers generated prior to the beginning of the protocol. The process of randomization of patients in the groups will be carried out using random blocks. The method for blinding the study will be carried out using sealed envelopes and will include the blinding of the researchers, evaluators and those responsible for statistical analysis, but will not include the blinding of the attending physician and the patients.
The data will be stored in Excel and analyzed statistically using STATA 12.0 software. The statistical approach will be carried out through the "intention-to-treat" model. The assessment of ventilatory and hemodynamic parameters between the groups will be performed using ANOVA associated with Bonferroni for parametric data or the Kruskal-Wallis test associated with the Mann-Whitney test for nonparametric data. For categorical variables, we will use Fisher's exact test or Chi-square test. Repeated measures ANOVA will be used to assess outcomes between treatment groups over the follow-up period. In order to control important variables, such as surgical time, surgical complications, age, body mass index, and ASA classification (comorbidities), a statistical approach to assess confounding factors (linear regression model) will be performed after the period data collection. Results will be considered statistically significant when type I (P) error is less than 0.05.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Regional anesthesia
- Keywords
- postoperative pulmonary complications, vascular surgery, regional anesthesia, mechanical ventilation
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaProcedure or surgery
Also called Spinal anesthesia
Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia | Experimental | Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1). Receives: Procedure: Regional anesthesia |
| General anesthesia | Active comparator | Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2). Receives: Procedure: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary complications.
To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary endpoint composed: mild respiratory failure / hypoxemia, severe respiratory failure, suspected pulmonary infection , atelectasis, acute lung injury, barotrauma, pulmonary infiltrate, pleural effusion, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb bypass surgery.
Measured: 7 days
Secondary outcomes (5)
Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs)
To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs) in the perioperative period of patients undergoing lower limb bypass surgery.
Measured: 7 days
Incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period.
To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period of patients undergoing lower limb bypass surgery.
Measured: 7 days
Perioperative pulmonary, gasometric and inflammatory physiological parameters.
To evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on perioperative pulmonary, gasometric and inflammatory physiological parameters of patients undergoing lower limb bypass surgery.
Measured: 7 days
Hemodynamic parameters in the perioperative period.
To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on hemodynamic parameters in the perioperative period of patients undergoing lower limb bypass surgery.
Measured: 7 days
Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay.
To evaluate the effects of spinal neuraxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of various extrapulmonary complications (Annex 2), in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay in patients undergoing lower limb bypass surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start28 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre P Schmidt, Principal investigator, Hospital de Clinicas de Porto AlegreCristiano F Andrade, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566016
- Sponsor's protocol ID
- 95165518.6.0000.5327
- Other IDs
- RBR-72fpz2
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Effects on the Incidence of Postoperative Pulmonary Complications.
- ClinicalTrials.gov ID
- NCT04566016
- Acronym / sponsor ID
- 95165518.6.0000.5327
- Conditions
- Peripheral Vascular Diseases
- Keywords
- postoperative pulmonary complications, vascular surgery, regional anesthesia, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 28 Sep 2020 (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.
The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
Detailed description
In this prospective and randomized study, only adult ASA II to IV patients, aged over 18 years, scheduled to undergo lower limb arterial revascularization surgery at the Hospital de Clínicas in Porto Alegre and at the Hospital Nossa Senhora da Conceição will be included.
The study will be designed as a prospective clinical trial. Patients will be randomly allocated for treatment with spinal neuraxial anesthesia associated with spontaneous ventilation (nasal glasses with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume from 6 to 8 ml / kg of the assumed weight and PEEP of 5 cmH2O - Group 2).
Sampling will be carried out for convenience, including patients routinely seen in the operating room of the hospitals involved and who meet the inclusion and exclusion criteria of this study. The allocation of patients will be performed through a table of random numbers generated prior to the beginning of the protocol. The process of randomization of patients in the groups will be carried out using random blocks. The method for blinding the study will be carried out using sealed envelopes and will include the blinding of the researchers, evaluators and those responsible for statistical analysis, but will not include the blinding of the attending physician and the patients.
The data will be stored in Excel and analyzed statistically using STATA 12.0 software. The statistical approach will be carried out through the "intention-to-treat" model. The assessment of ventilatory and hemodynamic parameters between the groups will be performed using ANOVA associated with Bonferroni for parametric data or the Kruskal-Wallis test associated with the Mann-Whitney test for nonparametric data. For categorical variables, we will use Fisher's exact test or Chi-square test. Repeated measures ANOVA will be used to assess outcomes between treatment groups over the follow-up period. In order to control important variables, such as surgical time, surgical complications, age, body mass index, and ASA classification (comorbidities), a statistical approach to assess confounding factors (linear regression model) will be performed after the period data collection. Results will be considered statistically significant when type I (P) error is less than 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | Experimental | Procedure: Regional anesthesiaPatients scheduled for lower limb arterial bypass surgery and allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1). |
| General anesthesia | Active comparator | Procedure: Regional anesthesiaPatients scheduled for lower limb arterial bypass surgery and allocated for treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients ASA II to IV; age greater than 18 years; scheduled for arterial revascularization surgery on lower limbs.
Key exclusion criteria (1 listed)
- Patients with a body mass index above 40 kg / m2 who underwent emergency surgery, with a history of pulmonary surgery, persistent hemodynamic instability in the preoperative period, history of asthma or chronic use of corticotherapy, or patients with history neuromuscular disorder. Patients with a history of use of anticoagulants or antiplatelet agents in the preoperative period who contraindicate the performance of spinal anesthesia will also be excluded from the study. In this study, only patients with peripheral vascular disease with critical and symptomatic ischemia in the lower limbs and scheduled to undergo elective arterial revascularization of the lower limbs will be included, and all patients with acute vascular obstruction or other associated vascular complications will be excluded.
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 |
|---|---|---|
| Regional anesthesiaAlso: Spinal anesthesiaPatients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2). | Procedure or surgery | General anesthesia, Regional anesthesia |
Primary outcome
Incidence of postoperative pulmonary complications.
Time frame: 7 days
To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary endpoint composed: mild respiratory failure / hypoxemia, severe respiratory failure, suspected pulmonary infection , atelectasis, acute lung injury, barotrauma, pulmonary infiltrate, pleural effusion, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb bypass surgery.
5 secondary outcomes
Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs)
Time frame: 7 days
Incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period.
Time frame: 7 days
Perioperative pulmonary, gasometric and inflammatory physiological parameters.
Time frame: 7 days
Hemodynamic parameters in the perioperative period.
Time frame: 7 days
Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Andre P Schmidt principal investigator
Hospital de Clinicas de Porto Alegre
Cristiano F Andrade study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia in people with Peripheral Vascular Diseases, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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 7 Apr 2022. 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 Brazil. 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?
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?
Incidence of postoperative pulmonary complications. (time frame: 7 days). 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 7 Apr 2022.