Mucosal Injury Using Pharyngeal Packing

NCT02757300 | Withdrawn

• 1 other identifier: mho 004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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

  Second postoperative day

Study Arms (2)

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.

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.

Device: Without Hypopharyngeal packing

Interventions

Hypopharyngeal packing DEVICE

After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.

Hypopharyngeal packing

Without Hypopharyngeal packing DEVICE

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.

Without hypopharyngeal packing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery of the sinuses
• Patients over 18 years of age
• Duration of surgery \> 1h

You may not qualify if:

• Refusal of the patient
• Patients under 18 years of age
• Chemotherapy with antiemetic medication
• Combined surgery (for example tonsillectomie and sinus surgery)
• Pregnancy

Sponsors & Collaborators

• Marienhospital Osnabrück: lead

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Martin Beiderlinden, PD

  Marienhospital Osnabrück

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.D. Dr. med. M. Beiderlinden

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 1, 2022

Record last verified: 2022-08