HealthyNCT03745443
Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia
A study testing increase and decrease positive end-expiratory pressure in people with Healthy, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
Trial summary
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- increase and decrease positive end-expiratory pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSerbia
- Study dates
- 20 Jan 2017to 25 Jun 2017
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 3-7; ASA I and II
- absence of cardiovascular and respiratory comorbidity
Who cannot join
- current or recent (up to 4 weeks) upper airway infection
- present of gastroesophageal reflux
- allergic reactions to anesthetics
- contraindication to chosen anesthetics
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Institute for Mother and Child Health Care dr Vukan Cupic
Belgrade, 11000
About this study
Official title: The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively. Positive end-expiratory pressure (PEEP) is distending pressure that prevents alveolar collapse during mechanical ventilation and is a part of recruitment maneuver that is often used in patients on mechanical ventilation. Overall effect of PEEP is improvement in lung function. PEEP can have adverse effects on hemodynamics. The objective of this study was to assess the effect of step up and down PEEP titration on lung function and hemodynamics in healthy preschool children during general anesthesia. One group of children was ventilated with constant PEEP. the other was submitted to PEEP titration. Changes in lung compliance, gas exchange and hemodynamic status were documented as well as any unwanted effects.
Read the detailed description
Seventy preschool children American Society of Anesthesiologists classification system (ASA) I and II scheduled for non-cardiothoracic surgery were allocated in two groups. Interventional group (n=35) received PEEP titration and Control group (n=35) didn't. They were ventilated only with PEEP 3. PEEP titration: In Intervention group, 20 minutes before the end of anesthesia PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then PEEP was reduced by 2 on every 5 breaths to 5 and remain as until awakening. Total time to perform titration was 5 minutes. Blood was collected in both groups, in equal points of time that is: after induction, 20 minutes before the end of surgery and after the end of surgery (20th minute). Investigators tested differences of outcome variables between groups and within the Interventional group before and after PEEP titration. Hemodynamic monitoring and monitoring of lung function were conducted in Interventional group to observe changes during PEEP titration.
- Conditions
- Healthy
- Being tested
- increase and decrease positive end-expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increase and decrease positive end-expiratory pressureProcedure or surgery
Also called ventilation with PEEP 3
20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then, PEEP was reduced by 2 on every 5 breaths to 5 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention: increase and decrease positive end-expiratory pressure. PEEP titration: 20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11 ventilation was maintained on PEEP 11 for 2 minutes.Then, PEEP was reduced by 2 for every 5 breaths to 5.Total time to titrate was 5 minutes. Receives: Procedure: increase and decrease positive end-expiratory pressure |
| Control | No intervention | Ventilation with PEEP 3 during anesthesia and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of oxygen
measured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.
Measured: 10 minutes after PEEP titration
Partial pressure of carbon dioxide
measured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group
Measured: 10 minutes after PEEP titration
Lung compliance
spirometric measurement of dynamic lung compliance at the end of surgery in Interventional and Control group
Measured: 10 minutes after PEEP titration
Lung compliance
spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group
Measured: 5 minutes
Secondary outcomes (3)
postoperative hemoglobin oxygen saturation
hemoglobin oxygen saturation measured with puls oximeter
Measured: 4 hours after extubation
intraoperative hemodynamic status
invasive blood pressure monitoring during PEEP titration in Interventional group
Measured: 5 minutes
intraoperative respiratory adverse effect
airway pressure monitoring during PEEP titration in Interventional group
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Jan 2017
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan Cupic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Mandras, Mother and Child Health Institute of Serbia Dr Vukan Cupic
- Investigators
- Ana Mandras, MD, Principal investigator, Institute for Mother and Child Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745443
- Sponsor's protocol ID
- 8/30,2017
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doras C, Le Guen M, Petak F, Habre W. Cardiorespiratory effects of recruitment maneuvers and positive end expiratory pressure in an experimental context of acute lung injury and pulmonary hypertension. BMC Pulm Med. 2015 Jul 31;15:82. doi: 10.1186/s12890-015-0079-y.
PubMed 26228052Boriosi JP, Sapru A, Hanson JH, Asselin J, Gildengorin G, Newman V, Sabato K, Flori HR. Efficacy and safety of lung recruitment in pediatric patients with acute lung injury. Pediatr Crit Care Med. 2011 Jul;12(4):431-6. doi: 10.1097/PCC.0b013e3181fe329d.
PubMed 21057351Cruces P, Gonzalez-Dambrauskas S, Cristiani F, Martinez J, Henderson R, Erranz B, Diaz F. Positive end-expiratory pressure improves elastic working pressure in anesthetized children. BMC Anesthesiol. 2018 Oct 24;18(1):151. doi: 10.1186/s12871-018-0611-8.
PubMed 30355345Mascotto G, Bizzarri M, Messina M, Cerchierini E, Torri G, Carozzo A, Casati A. Prospective, randomized, controlled evaluation of the preventive effects of positive end-expiratory pressure on patient oxygenation during one-lung ventilation. Eur J Anaesthesiol. 2003 Sep;20(9):704-10. doi: 10.1017/s0265021503001145.
PubMed 12974591
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Efficacy and Safety of Step-wise up and Down PEEP Titration in Healthy Pediatric Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03745443
- Acronym / sponsor ID
- 8/30,2017
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan CupicUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 19 Nov 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.
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively. Positive end-expiratory pressure (PEEP) is distending pressure that prevents alveolar collapse during mechanical ventilation and is a part of recruitment maneuver that is often used in patients on mechanical ventilation. Overall effect of PEEP is improvement in lung function. PEEP can have adverse effects on hemodynamics. The objective of this study was to assess the effect of step up and down PEEP titration on lung function and hemodynamics in healthy preschool children during general anesthesia. One group of children was ventilated with constant PEEP. the other was submitted to PEEP titration. Changes in lung compliance, gas exchange and hemodynamic status were documented as well as any unwanted effects.
Detailed description
Seventy preschool children American Society of Anesthesiologists classification system (ASA) I and II scheduled for non-cardiothoracic surgery were allocated in two groups. Interventional group (n=35) received PEEP titration and Control group (n=35) didn't. They were ventilated only with PEEP 3. PEEP titration: In Intervention group, 20 minutes before the end of anesthesia PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then PEEP was reduced by 2 on every 5 breaths to 5 and remain as until awakening. Total time to perform titration was 5 minutes. Blood was collected in both groups, in equal points of time that is: after induction, 20 minutes before the end of surgery and after the end of surgery (20th minute). Investigators tested differences of outcome variables between groups and within the Interventional group before and after PEEP titration. Hemodynamic monitoring and monitoring of lung function were conducted in Interventional group to observe changes during PEEP titration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized parallel controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: increase and decrease positive end-expiratory pressureIntervention: increase and decrease positive end-expiratory pressure. PEEP titration: 20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11 ventilation was maintained on PEEP 11 for 2 minutes.Then, PEEP was reduced by 2 for every 5 breaths to 5.Total time to titrate was 5 minutes. |
| Control | No intervention | –Ventilation with PEEP 3 during anesthesia and surgery |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 3-7; ASA I and II
- absence of cardiovascular and respiratory comorbidity
Key exclusion criteria (4 listed)
- current or recent (up to 4 weeks) upper airway infection
- present of gastroesophageal reflux
- allergic reactions to anesthetics
- contraindication to chosen anesthetics
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 |
|---|---|---|
| increase and decrease positive end-expiratory pressureAlso: ventilation with PEEP 320 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then, PEEP was reduced by 2 on every 5 breaths to 5 cmH2O | Procedure or surgery | Intervention group |
Primary outcome
Partial pressure of oxygen
Time frame: 10 minutes after PEEP titration
measured partial pressure of oxygen in arterial blood at the end of surgery in Interventional and Control group.
Partial pressure of carbon dioxide
Time frame: 10 minutes after PEEP titration
measured partial pressure carbon dioxide in arterial blood at the end of surgery in Interventional and in Control group
Lung compliance
Time frame: 10 minutes after PEEP titration
spirometric measurement of dynamic lung compliance at the end of surgery in Interventional and Control group
Lung compliance
Time frame: 5 minutes
spirometric measurement of dynamic lung compliance on different PEEP levels in Interventional group
3 secondary outcomes
postoperative hemoglobin oxygen saturation
Time frame: 4 hours after extubation
intraoperative hemodynamic status
Time frame: 5 minutes
intraoperative respiratory adverse effect
Time frame: 5 minutes
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 27 Nov 2018.
- Background: PubMed 26228052Doras C, Le Guen M, Petak F, Habre W. Cardiorespiratory effects of recruitment maneuvers and positive end expiratory pressure in an experimental context of acute lung injury and pulmonary hypertension. BMC Pulm Med. 2015 Jul 31;15:82. doi: 10.1186/s12890-015-0079-y.
- Background: PubMed 21057351Boriosi JP, Sapru A, Hanson JH, Asselin J, Gildengorin G, Newman V, Sabato K, Flori HR. Efficacy and safety of lung recruitment in pediatric patients with acute lung injury. Pediatr Crit Care Med. 2011 Jul;12(4):431-6. doi: 10.1097/PCC.0b013e3181fe329d.
- Background: PubMed 30355345Cruces P, Gonzalez-Dambrauskas S, Cristiani F, Martinez J, Henderson R, Erranz B, Diaz F. Positive end-expiratory pressure improves elastic working pressure in anesthetized children. BMC Anesthesiol. 2018 Oct 24;18(1):151. doi: 10.1186/s12871-018-0611-8.
- Results publication: PubMed 12974591Mascotto G, Bizzarri M, Messina M, Cerchierini E, Torri G, Carozzo A, Casati A. Prospective, randomized, controlled evaluation of the preventive effects of positive end-expiratory pressure on patient oxygenation during one-lung ventilation. Eur J Anaesthesiol. 2003 Sep;20(9):704-10. doi: 10.1017/s0265021503001145.
- 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.
Ana Mandras, MD principal investigator
Institute for Mother and Child Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increase and decrease positive end-expiratory pressure in people with Healthy, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
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 4 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 27 Nov 2018. 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 Serbia. 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?
Partial pressure of oxygen (time frame: 10 minutes after PEEP titration). The study lists 4 primary outcomes in all. 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 NCT03745443, which also lists 4 linked publications.
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 27 Nov 2018.