Atelectasis, Postoperative PulmonaryRCTNCT06589011
Postoperative Hypoxemia in Obese Patients
A study testing Pressure Support Ventilation and spontaneously assisted breathing in people with Atelectasis, Postoperative Pulmonary and Bariatric Surgery, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Postoperative atelectasis can cause postoperative hypoxia which might be avoided by applying pressure support during extubation of obese patients undergoing bariatric surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary, Bariatric Surgery
- What is being tested?
- Pressure Support Ventilation and spontaneously assisted breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 15 Jun 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-III patients.
- aged from 18-60 years old.
- body mass index :(BMI) ≥ 35 Kg/m2 scheduled for laparoscopic bariatric surgery.
Who cannot join
- age ≤18 or ≥ 60 years.
- pregnant females.
- underlying lung pathology, moderate to severe impairment of RFT, previous lung surgery, pneumothorax and pleural effusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Hypoxemia in Obese Patients: Pressure Support Versus Spontaneous Ventilation During Anesthetic Emergence in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
Postoperative atelectasis can cause postoperative hypoxia which might be avoided by applying pressure support during extubation of obese patients undergoing bariatric surgeries.
Read the detailed description
Postoperative atelectasis is one of the most common pulmonary complications in surgical patients, and a fair majority of studies have suggested that postoperative atelectasis is harmful. It increases the risk of hypoxemia and forms the pathophysiologic basis for other postoperative pulmonary complications. Atelectasis can last for several days after surgery impairing respiratory function, and ultimately delaying patient discharge.
Obese patients are more likely than non-obese patients to develop atelectasis that resolves more slowly. This is because of a marked impairment of the respiratory mechanics (decreased chest wall and lung compliance and decreased functional residual capacity) promoting airway closure with reduction of the oxygenation index (Pao2/ PAo2) to a greater extent than in healthy-weight +subjects . Also the weight of the abdomen makes diaphragmatic excursions more difficult, especially when recumbent or supine, which is intensified in the setting of diaphragmatic paralysis associated with neuromuscular blockade.
Although there have been many studies regarding ventilatory techniques to reduce postoperative pulmonary complications, only a few studies have focused on the period of recovery from anesthesia. The benefits obtained from the protective ventilation techniques may be lost during this emergence process. Whalen et al. found that recruitment maneuver and the application of positive end-expiratory pressure (PEEP) improved intraoperative oxygenation, but the effect dissipated promptly after extubation. Many studies have observed the development of atelectasis during the emergence period. Furthermore, it is estimated that the emergence period contributes to approximately 39% of the total amount of postoperative atelectasis.
Currently, we allow patients to breathe spontaneously and assist their respiration intermittently during the transition from controlled ventilation to spontaneous respiration while assessing whether the patients have enough power to breathe without assistance. However, patients who are spontaneously breathing remain under the influence of residual anesthetic agents and neuromuscular blockers and may not have restored their functional residual capacity, subsequently developing atelectasis. In addition, pain-induced respiratory restriction or respiratory muscle fatigue during spontaneous respiration may increase the risk of atelectasis.
Pressure support ventilation is widely used for weaning from mechanical ventilation in the intensive care unit (ICU) and is recently available in anesthesia machines. Pressure support ventilation applies a fixed amount of pressure the physician selects to the patients throughout each breath to augment their own respiration and is one of the most comfortable ventilation modes for patients. In these aspects, pressure support ventilation during recovery from anesthesia may reduce postoperative atelectasis compared to spontaneous respiration with intermittent manual assistance. To date, few studies have assessed the effect of pressure support ventilation on postoperative atelectasis.
Moreover, laparoscopic surgery are associated with a higher risk of postoperative atelectasis due to the high intra-abdominal pressure which pushes the diaphragm upward and subsequently results in the collapse of the alveoli.
Our hypothesis is that pressure support ventilation will reduces the postoperative hypoxemia and atelectasis compared to spontaneous respiration with intermittent manual assistance during anesthetic emergence in obese patients undergoing laparoscopic surgery.
Aim of the study:
The aim of our study is to assess the possible superiority of pressure support ventilation compared to spontaneous respiration with intermittent manual assistance to reduce postoperative hypoxemia and atelectasis during anesthetic emergence in obese patients undergoing laparoscopic surgery.
- Being tested
- Pressure Support Ventilation, spontaneously assisted breathing
- Keywords
- pressure support, postoperative atelectasis, obese patients, bariatric surgery
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Support VentilationOther
The initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min
spontaneously assisted breathingOther
The basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support | Active comparator | The initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min (safety backup ventilation setting, VT, 8 ml/kg of predicted body weight; and PEEP, 5 cm H2O). The flow trigger and end of breath were set at 2 l/min and 30% of peak flow, respectively. Receives: Other: Pressure Support Ventilation |
| control group | Placebo comparator | The emergence process was led by the discretion of the attending anesthesiologist. The basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance. Receives: Other: spontaneously assisted breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial Pao2
Arterial blood sample was with drawn from the patients on room air after extubation
Measured: immediately after arrival to the PACU within 10 minutes after extubation.
Secondary outcomes (2)
Postoperative atelectasis
diagnosed by chest x-ray
Measured: 30 minutes after arrival to the PACU
respiratory rescue measures
need for oxygen supplementation or mechanical ventilation
Measured: within 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2023
- Primary completion1 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atelectasis, Postoperative PulmonaryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pressure support versus spontaneous assisted ventilation during extubation from bariatric surgeries.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
- Investigators
- Moshira Sayed Lecturer of anesthesia and intensive care, M.D., Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589011
- Sponsor's protocol ID
- PT(735)
- Other IDs
- PT(735), (FWA#000010609)
- Acronym
- RCT
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available upon request from the principal investigator
Publications
Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
PubMed 31587835van Kaam AH, Lachmann RA, Herting E, De Jaegere A, van Iwaarden F, Noorduyn LA, Kok JH, Haitsma JJ, Lachmann B. Reducing atelectasis attenuates bacterial growth and translocation in experimental pneumonia. Am J Respir Crit Care Med. 2004 May 1;169(9):1046-53. doi: 10.1164/rccm.200312-1779OC. Epub 2004 Feb 20.
PubMed 14977624Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.
PubMed 34610099
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypoxemia in Obese Patients: Pressure Support Versus Spontaneous Ventilation During Anesthetic Emergence in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06589011
- Acronym / sponsor ID
- RCT / PT(735)
- Keywords
- pressure support, postoperative atelectasis, obese patients, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Postoperative atelectasis can cause postoperative hypoxia which might be avoided by applying pressure support during extubation of obese patients undergoing bariatric surgeries.
Detailed description
Postoperative atelectasis is one of the most common pulmonary complications in surgical patients, and a fair majority of studies have suggested that postoperative atelectasis is harmful. It increases the risk of hypoxemia and forms the pathophysiologic basis for other postoperative pulmonary complications. Atelectasis can last for several days after surgery impairing respiratory function, and ultimately delaying patient discharge.
Obese patients are more likely than non-obese patients to develop atelectasis that resolves more slowly. This is because of a marked impairment of the respiratory mechanics (decreased chest wall and lung compliance and decreased functional residual capacity) promoting airway closure with reduction of the oxygenation index (Pao2/ PAo2) to a greater extent than in healthy-weight +subjects . Also the weight of the abdomen makes diaphragmatic excursions more difficult, especially when recumbent or supine, which is intensified in the setting of diaphragmatic paralysis associated with neuromuscular blockade.
Although there have been many studies regarding ventilatory techniques to reduce postoperative pulmonary complications, only a few studies have focused on the period of recovery from anesthesia. The benefits obtained from the protective ventilation techniques may be lost during this emergence process. Whalen et al. found that recruitment maneuver and the application of positive end-expiratory pressure (PEEP) improved intraoperative oxygenation, but the effect dissipated promptly after extubation. Many studies have observed the development of atelectasis during the emergence period. Furthermore, it is estimated that the emergence period contributes to approximately 39% of the total amount of postoperative atelectasis.
Currently, we allow patients to breathe spontaneously and assist their respiration intermittently during the transition from controlled ventilation to spontaneous respiration while assessing whether the patients have enough power to breathe without assistance. However, patients who are spontaneously breathing remain under the influence of residual anesthetic agents and neuromuscular blockers and may not have restored their functional residual capacity, subsequently developing atelectasis. In addition, pain-induced respiratory restriction or respiratory muscle fatigue during spontaneous respiration may increase the risk of atelectasis.
Pressure support ventilation is widely used for weaning from mechanical ventilation in the intensive care unit (ICU) and is recently available in anesthesia machines. Pressure support ventilation applies a fixed amount of pressure the physician selects to the patients throughout each breath to augment their own respiration and is one of the most comfortable ventilation modes for patients. In these aspects, pressure support ventilation during recovery from anesthesia may reduce postoperative atelectasis compared to spontaneous respiration with intermittent manual assistance. To date, few studies have assessed the effect of pressure support ventilation on postoperative atelectasis.
Moreover, laparoscopic surgery are associated with a higher risk of postoperative atelectasis due to the high intra-abdominal pressure which pushes the diaphragm upward and subsequently results in the collapse of the alveoli.
Our hypothesis is that pressure support ventilation will reduces the postoperative hypoxemia and atelectasis compared to spontaneous respiration with intermittent manual assistance during anesthetic emergence in obese patients undergoing laparoscopic surgery.
Aim of the study:
The aim of our study is to assess the possible superiority of pressure support ventilation compared to spontaneous respiration with intermittent manual assistance to reduce postoperative hypoxemia and atelectasis during anesthetic emergence in obese patients undergoing laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- pressure support versus spontaneous assisted ventilation during extubation from bariatric surgeries.
| Arm | Type | Receives |
|---|---|---|
| Pressure support | Active comparator | Other: Pressure Support VentilationThe initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min (safety backup ventilation setting, VT, 8 ml/kg of predicted body weight; and PEEP, 5 cm H2O). The flow trigger and end of breath were set at 2 l/min and 30% of peak flow, respectively. |
| control group | Placebo comparator | Other: spontaneously assisted breathingThe emergence process was led by the discretion of the attending anesthesiologist. The basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-III patients.
- aged from 18-60 years old.
- body mass index :(BMI) ≥ 35 Kg/m2 scheduled for laparoscopic bariatric surgery.
Key exclusion criteria (3 listed)
- age ≤18 or ≥ 60 years.
- pregnant females.
- underlying lung pathology, moderate to severe impairment of RFT, previous lung surgery, pneumothorax and pleural effusion.
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 |
|---|---|---|
| Pressure Support VentilationThe initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min | Other | Pressure support |
| spontaneously assisted breathingThe basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance. | Other | control group |
Primary outcome
arterial Pao2
Time frame: immediately after arrival to the PACU within 10 minutes after extubation.
Arterial blood sample was with drawn from the patients on room air after extubation
2 secondary outcomes
Postoperative atelectasis
Time frame: 30 minutes after arrival to the PACU
respiratory rescue measures
Time frame: within 48 hours postoperatively
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 19 Sep 2024.
- Background: PubMed 31587835Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
- Background: PubMed 14977624van Kaam AH, Lachmann RA, Herting E, De Jaegere A, van Iwaarden F, Noorduyn LA, Kok JH, Haitsma JJ, Lachmann B. Reducing atelectasis attenuates bacterial growth and translocation in experimental pneumonia. Am J Respir Crit Care Med. 2004 May 1;169(9):1046-53. doi: 10.1164/rccm.200312-1779OC. Epub 2004 Feb 20.
- Background: PubMed 34610099Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.
- Individual participant dataSharing planned: No. data will be available upon request from the principal investigator
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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.
Moshira Sayed Lecturer of anesthesia and intensive care, M.D. principal investigator
Theodor Bilharz Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Support Ventilation and spontaneously assisted breathing in people with Atelectasis, Postoperative Pulmonary and Bariatric Surgery, run by Theodor Bilharz Research Institute at 1 site in Egypt.
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 3 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 19 Sep 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
arterial Pao2 (time frame: immediately after arrival to the PACU within 10 minutes 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 NCT06589011, which also lists 3 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 19 Sep 2024.