AnesthesiaNCT02519517
Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
A study testing Permissive hypercapnia in people with Anesthesia, run by Cairo University.
Trial summary
Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Permissive hypercapnia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Apr 2013
- 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 >18 yr
- elective pulmonary resection through thoracotomy.
Who cannot join
- Patients with pulmonary hypertension (systolic >50mmHg),
- intracranial hypertension or previous intracranial haemorrhage,
- pre-existing hypercapnia,
- co-existing metabolic acidosis,
- ischaemic heart disease,
- predicted postoperative FEV1<800 ml or <40% of the expected in pneumonectomy
- patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.
About this study
Official title: Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.
Read the detailed description
Investigators studied 15 patients scheduled for elective pulmonary resection through thoracotomy. Patients had a standardized management for thoracotomies. Initial VT 10ml/ kg was reduced to 8ml/kg after OLV and the rate adjusted to maintain PaCO2 30-35 mm Hg. Haemodynamic, respiratory variables and echocardiographic data (Tei index and TAPSE) were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures ANOVA, with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.
- Conditions
- Anesthesia
- Being tested
- Permissive hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permissive hypercapniaProcedure or surgery
During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated
| Study group | Role | What they receive |
|---|---|---|
| permissive hypercapnia | Experimental | during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated Receives: Procedure: Permissive hypercapnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular systolic and diastolic functions measured by Tei index
Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519517
- Sponsor's protocol ID
- acute permissive hypercapnia
- Status last verified
- Aug 2015
- First submitted
- 20 Jun 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
- ClinicalTrials.gov ID
- NCT02519517
- Acronym / sponsor ID
- acute permissive hypercapnia
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Aug 2015 (estimated)
- 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.
Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.
Detailed description
Investigators studied 15 patients scheduled for elective pulmonary resection through thoracotomy. Patients had a standardized management for thoracotomies. Initial VT 10ml/ kg was reduced to 8ml/kg after OLV and the rate adjusted to maintain PaCO2 30-35 mm Hg. Haemodynamic, respiratory variables and echocardiographic data (Tei index and TAPSE) were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures ANOVA, with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| permissive hypercapnia | Experimental | Procedure: Permissive hypercapniaduring one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult >18 yr
- elective pulmonary resection through thoracotomy.
Key exclusion criteria (7 listed)
- Patients with pulmonary hypertension (systolic >50mmHg),
- intracranial hypertension or previous intracranial haemorrhage,
- pre-existing hypercapnia,
- co-existing metabolic acidosis,
- ischaemic heart 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 |
|---|---|---|
| Permissive hypercapniaDuring one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated | Procedure or surgery | permissive hypercapnia |
Primary outcome
Right ventricular systolic and diastolic functions measured by Tei index
Time frame: Intraoperative
Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions
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 11 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Permissive hypercapnia in people with Anesthesia, run by Cairo University.
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 7 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 11 Aug 2015. 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?
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?
Right ventricular systolic and diastolic functions measured by Tei index (time frame: Intraoperative). 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 11 Aug 2015.