AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

Egypt1 site
  • Theodor Bilharz Research institute

    Giza, Cairo Governorate, +020

Other trials in Egypt

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 groups in NCT06589011
Study groupRoleWhat they receive
Pressure supportActive comparatorThe 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 groupPlacebo comparatorThe 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.

  1. 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)
  1. Postoperative atelectasis

    diagnosed by chest x-ray

    Measured: 30 minutes after arrival to the PACU

  2. 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.

  1. First posted19 Sep 2024
  2. Study start1 May 2023
  3. Primary completion1 Jun 2024
  4. Study completion15 Jun 2024

Resources

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)
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 31587835
  • van 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 14977624
  • Jeong 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in