Sore ThroatNCT02757300
Mucosal Injury Using Pharyngeal Packing
A study testing Hypopharyngeal packing and Without Hypopharyngeal packing in people with Sore Throat, run by Marienhospital Osnabrück.
Trial summary
After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat
- What is being tested?
- Hypopharyngeal packing and Without Hypopharyngeal packing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2018
- 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
- Surgery of the sinuses
- Patients over 18 years of age
- Duration of surgery > 1h
Who cannot join
- Refusal of the patient
- Patients under 18 years of age
- Chemotherapy with antiemetic medication
- Combined surgery (for example tonsillectomie and sinus surgery)
- Pregnancy
About this study
Official title: Incidence of Mucosal Injury Using Pharyngeal Packing in Surgery of the Nasal Sinuses
After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
Read the detailed description
Aim of the study
Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population.
Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV.
Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being.
To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective:
- Does pharyngeal packing during sinus surgery increase the incidence of mucosal injury?
- Conditions
- Sore Throat
- Being tested
- Hypopharyngeal packing, Without Hypopharyngeal packing
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopharyngeal packingDevice
After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.
Without Hypopharyngeal packingDevice
After introduction and orotracheal intubation the patient will pass the operation without hypopharyngeal packing with a short tip coming out the mouth to imitate a packing.
| Study group | Role | What they receive |
|---|---|---|
| Hypopharyngeal packing | Experimental | Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups.
After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay. Receives: Device: Hypopharyngeal packing |
| Without hypopharyngeal packing | Active comparator | Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups.
After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay. Receives: Device: Without Hypopharyngeal packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of mucosal injury
Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management
Measured: Second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionJul 2018
Why it stopped: Study performer moved away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies 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
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marienhospital Osnabrück
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia Jetten, Marienhospital Osnabrück
- Investigators
- Martin Beiderlinden, PD, Study director, Marienhospital Osnabrück
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757300
- Sponsor's protocol ID
- mho 004
- Status last verified
- Aug 2022
- First submitted
- 19 Apr 2016
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Mucosal Injury Using Pharyngeal Packing in Surgery of the Nasal Sinuses
- ClinicalTrials.gov ID
- NCT02757300
- Acronym / sponsor ID
- mho 004
- Conditions
- Sore Throat
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study performer moved away
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marienhospital OsnabrückUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 May 2016 (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.
After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
Detailed description
Aim of the study
Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population.
Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV.
Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being.
To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective:
- Does pharyngeal packing during sinus surgery increase the incidence of mucosal injury?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypopharyngeal packing | Experimental | Device: Hypopharyngeal packingPatients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay. |
| Without hypopharyngeal packing | Active comparator | Device: Without Hypopharyngeal packingPatients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery of the sinuses
- Patients over 18 years of age
- Duration of surgery > 1h
Key exclusion criteria (5 listed)
- Refusal of the patient
- Patients under 18 years of age
- Chemotherapy with antiemetic medication
- Combined surgery (for example tonsillectomie and sinus surgery)
- Pregnancy
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 |
|---|---|---|
| Hypopharyngeal packingAfter introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed. | Device | Hypopharyngeal packing |
| Without Hypopharyngeal packingAfter introduction and orotracheal intubation the patient will pass the operation without hypopharyngeal packing with a short tip coming out the mouth to imitate a packing. | Device | Without hypopharyngeal packing |
Primary outcome
Incidence and severity of mucosal injury
Time frame: Second postoperative day
Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Martin Beiderlinden, PD study director
Marienhospital Osnabrück
Questions about this trial
What is this clinical trial studying?
A study testing Hypopharyngeal packing and Without Hypopharyngeal packing in people with Sore Throat, run by Marienhospital Osnabrück.
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 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: withdrawn, as of the sponsor's last update on 1 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence and severity of mucosal injury (time frame: Second postoperative day). 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 1 Sep 2022.