SurgeryVent-HypNCT01891838
Mode of Ventilation and Bleeding During Transsphenoidal Surgery
A study of Surgery, run by Hopital Foch at 1 site in France.
Trial summary
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Mar 2015
- 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
- Aged > 18 years
- Patients scheduled for transsphenoidal surgery for pituitary adenomas
Who cannot join
- Pregnancy
- Obesity (BMI> 35)
- Known respiratory disease
- Redo surgery
- Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
Read the detailed description
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
- group Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- group Pressure-controlled ventilation: initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- In both groups, the fraction of inspired oxygen is 50%. A recruitment maneuver is performed if the blood oxygen saturation became less than 92%.
- Conditions
- Surgery
- Being tested
- Volume controlled ventilation, Pressure-controlled ventilation
- Keywords
- surgery, transsphenoidal surgery, pituitary adenoma, mechanical ventilation, bleeding
- Medical subject headings
- Pituitary Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume controlled ventilationProcedure or surgery
Pressure-controlled ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Volume controlled ventilation | Active comparator | Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg. Receives: Procedure: Volume controlled ventilation |
| Pressure-controlled ventilation | Experimental | initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg Receives: Procedure: Pressure-controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding
intraoperative bleeding is estimated by the operator (always the same) as minimal (1), low (3), with no significant change in the conduct of the surgical procedure (5) with significant change in the conduct of surgical procedure (7). Intermediate levels are used to rate the levels of intermediate severity.
Measured: 1 hour postoperatively
Secondary outcomes (7)
generated plateau pressures
mean ventilatory plateau pressure during surgery
Measured: one hour after surgery
realisation of predefined objectives of minute ventilation
time spent with the predefined objectives of minute ventilation
Measured: one hour after surgery
changes of ventilation mode
number of changes of ventilation mode
Measured: one hour after surgery
arterial desaturation
number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery
Measured: one hour after surgery
recruitment maneuver
number of recruitment maneuver
Measured: one hour after surgery
duration of the surgical procedure
duration from surgical incision to end of the surgical procedure
Measured: one hour after surgery
endocrine healing
return to a low level of the abnormal endocrin abnormalities
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
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 SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891838
- Sponsor's protocol ID
- 2012/15
- Other IDs
- 2012-A00397-36
- Acronym
- Vent-Hyp
- Status last verified
- Oct 2016
- First submitted
- 29 Jun 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Guen M, Paternot A, Declerck A, Feliot E, Gayat E, Gaillard S, Fischler M. Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial. Medicine (Baltimore). 2019 Sep;98(38):e17254. doi: 10.1097/MD.0000000000017254.
PubMed 31567997
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding
- ClinicalTrials.gov ID
- NCT01891838
- Acronym / sponsor ID
- Vent-Hyp / 2012/15
- Conditions
- Surgery
- Keywords
- surgery, transsphenoidal surgery, pituitary adenoma, mechanical ventilation, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Jul 2013 (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.
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
Detailed description
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
- group Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- group Pressure-controlled ventilation: initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg.
- In both groups, the fraction of inspired oxygen is 50%. A recruitment maneuver is performed if the blood oxygen saturation became less than 92%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume controlled ventilation | Active comparator | Procedure: Volume controlled ventilationVolume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg. |
| Pressure-controlled ventilation | Experimental | Procedure: Pressure-controlled ventilationinitial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged > 18 years
- Patients scheduled for transsphenoidal surgery for pituitary adenomas
Key exclusion criteria (5 listed)
- Pregnancy
- Obesity (BMI> 35)
- Known respiratory disease
- Redo surgery
- Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
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 |
|---|---|---|
| Volume controlled ventilation | Procedure or surgery | Volume controlled ventilation |
| Pressure-controlled ventilation | Procedure or surgery | Pressure-controlled ventilation |
Primary outcome
intraoperative bleeding
Time frame: 1 hour postoperatively
intraoperative bleeding is estimated by the operator (always the same) as minimal (1), low (3), with no significant change in the conduct of the surgical procedure (5) with significant change in the conduct of surgical procedure (7). Intermediate levels are used to rate the levels of intermediate severity.
7 secondary outcomes
generated plateau pressures
Time frame: one hour after surgery
realisation of predefined objectives of minute ventilation
Time frame: one hour after surgery
changes of ventilation mode
Time frame: one hour after surgery
arterial desaturation
Time frame: one hour after surgery
recruitment maneuver
Time frame: one hour after surgery
duration of the surgical procedure
Time frame: one hour after surgery
endocrine healing
Time frame: three months after surgery
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 31 Oct 2016.
- Derived from this study: PubMed 31567997Le Guen M, Paternot A, Declerck A, Feliot E, Gayat E, Gaillard S, Fischler M. Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial. Medicine (Baltimore). 2019 Sep;98(38):e17254. doi: 10.1097/MD.0000000000017254.
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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.
Morgan Le Guen, MD principal investigator
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Surgery, run by Hopital Foch at 1 site in France.
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 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 31 Oct 2016. 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 France. 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?
intraoperative bleeding (time frame: 1 hour 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 NCT01891838, 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 31 Oct 2016.